Director, Global Regulatory Affairs
**Director, Global Regulatory Affairs - West Coast** A high-level position is now open for an exceptional Director of Global Regulatory Affairs based on the West Coast. This role offers the opportunity to spearhead regulatory strategies, navigate product development complexities and ensure compliance across international markets. As the guiding force behind our company's regulatory approach, your influence will be key to shaping market access and maintaining rigorous adherence to worldwide regulations. You'll join a dynamic team committed not only to innovation, but also exemplary standards that keep us at the forefront of our industry. **Role Responsibilities:** - Develop and implement cutting-edge Global regulatory strategies for clinical studies, marketing approvals, development plans and risk assessment, acting as the lead for the global regulatory program. - Prepare comprehensive submissions for Health Authority review. - Lead successful meetings with various global Health Authorities. - Manage regional teams towards cohesive global compliance efforts. - Provide High level oversight, direction, and mentorship to the team for general regulatory strategies and projects. - Reporting to CEO, CSO - Lead the submissions process **Skills Required:** *Regulatory Expertise*: 15+ years in the pharmaceutical industry, with deep understanding of pharmaceutical regulations necessary for steering products through complex approval processes globally. This candidate must have experience with gaining approval for new drug applications and biologic applications, as well as marketing authorizations, utilizing in house teams for the development of these products/submissions. *Strategic Guidance*: Ability provide long-term vision aligning with business objectives, and experience in managing early to late stage products, as well as post approval phases. This role will be leading the development of the company's global regulatory strategy *Leadership Abilities*: Superior managerial skill set fostering collaborative environment goal-oriented outcomes *Health Authority Interaction*: Must have experience leading FDA and/or EMA interactions/meetings This is an exciting opportunity to join a growing team that will make a difference in under-served patient's lives. If you have interest, please apply below.
Negotiable
San Francisco
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Regulatory Affairs Manager
Title: Regulatory Affairs Manager Summary: A leading global medical device company is seeking a Manager of Regulatory Affairs to join their innovative team. This key role involves managing regulatory submissions, including 510(k) filings, and working with both the US FDA and EU EMA to ensure compliance with regulatory standards. The Manager will collaborate with cross-functional teams to develop and execute regulatory strategies, prepare high-quality documentation, and support product development efforts. This position offers an exciting opportunity to contribute to the advancement of cutting-edge medical technologies that improve patient outcomes worldwide. The Manager will be responsible forโฆ Offering guidance, leadership, and coaching to Regulatory Affairs (RA) Associates. Providing expert technical advice on regulatory requirements for new products and modifications to existing ones. Managing, preparing, and reviewing regulatory submissions, including 510(k) filings and compliance with EU MDR standards. Collaborating with departments and cross-functional teams to communicate regulatory strategies effectively. Evaluating advertising and promotional materials to ensure alignment with local and international regulations. The Manager should have the following qualifications: Holds a bachelor's degree in engineering or physical/biological sciences. Possesses 8 years of experience in Regulatory Affairs, including 1+ year of direct or indirect management experience. Extensive experience with 510(k) filings and EU MDR submissions. Comprehensive knowledge of U.S. and international regulatory requirements for medical devices. Proven ability to provide leadership and mentorship to less experienced team members. Skilled in identifying, understanding, and resolving regulatory challenges.
Negotiable
England
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Senior Regulatory Affairs Quality Systems Specialist
Title: Senior Regulatory Affairs and Quality Systems Specialist The Regulatory Affairs and Quality Systems Specialist is responsible for supporting regulatory and quality assurance processes related to in vitro diagnostic (IVD) medical devices. This organization offers a dynamic and collaborative work environment where you have the opportunity to make a meaningful impact in the field of medical diagnostics. With a focus on innovation and excellence, this company provides ample opportunities for professional growth and development, supporting career advancement through hands-on experience and cross-functional collaboration. You will be empowered to contribute to projects that improve healthcare outcomes globally, particularly in the realm of in vitro diagnostic devices. Key Responsibilities Project Compliance and Oversight: Attend project meetings to ensure all medical device design, development, and manufacturing activities meet regulatory requirements, including U.S. FDA's QSR (21 CFR Part 820), ISO 13485, and other relevant standards. Regulatory Strategy Support: Collaborate with internal teams and external partners to develop and implement a global regulatory strategy to meet U.S. FDA requirements and support business goals. Quality System Management: Assist in the management of the organization's Quality System in relation to bringing medical device products to market, including document control and regulatory compliance. Regulatory Submissions: Provide guidance and support in the drafting and submission of regulatory filings, with a particular focus on FDA Q-Submissions and premarket notifications. Clinical and Validation Support: Assist in the preparation and review of technical documents, protocols, and data for clinical trials, validation, verification, and product manufacturing. Regulatory Documentation Management: Maintain regulatory files and databases to ensure accuracy and continuity of information across various platforms. Process Improvement and SOPs: Draft and update Standard Operating Procedures (SOPs) to ensure they reflect current regulatory practices and requirements. Post-market Activities: Manage adverse event reporting, medical device recalls, and product corrections/removals. Product Labeling Oversight: Ensure that product labeling, including Instructions for Use (IFU), complies with all applicable regulatory requirements. Risk Management and Lifecycle Support: Contribute to risk management activities and assist in monitoring product lifecycle changes. Third-Party Audits: Participate in internal and supplier audits, ensuring compliance with regulatory standards and quality system requirements. Qualifications Language Skills: Fluency in English (written and verbal) and Korean (written and verbal) is a Must Bachelor's degree in Engineering, Biology, Biochemistry, Microbiology, or a related field. 5-6 years of experience in a regulated industry, particularly in medical device quality assurance, regulatory affairs, or quality systems management. Experience with FDA and ISO 13485 regulations, including knowledge of IVD medical device regulations, risk management, and design controls. Regulatory Expertise: In-depth knowledge of FDA QSR (21 CFR Part 820), ISO 13485, and other relevant standards for medical device manufacturing. Problem Solving and Adaptability: Ability to adjust strategies and plans as business needs evolve. Stakeholder Communication: Strong interpersonal and communication skills to influence and align stakeholders across the organization. Leadership and Organization: Demonstrated leadership ability and project management skills in fast-paced environments. Technical Writing: Ability to draft and review complex technical documentation, regulatory submissions, and SOPs. Attention to Detail: High level of accuracy in data management and documentation. Time Management: Ability to prioritize multiple projects and meet deadlines in a dynamic environment. Public Speaking and Training: Experience speaking in large group settings and training teams on regulatory and quality requirements. Software Skills: Proficiency with MS Office (Word, Excel, PowerPoint, Outlook) is required. Travel Requirements: Must be willing to travel to US and international based offices
US$90000 - US$120000 per annum
Cincinnati
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Director Regulatory Affairs
Title: Director Regulatory Affairs A small sized diagnostics company is seeking a Director of Regulatory Affairs to lead the regulatory submissions, strategy, and maintenance activities for their existing products and new products in development. They are pioneering the field with innovative machine learning-based liquid biopsy mRNA expression tests, designed for both standard-of-care and pharmaceutical trials. These products are patented and unique to the cancer diagnostics market. This role reports directly into the CEO/CSO. Responsibilities: Register two prospective studies with the FDA Serve as the point of contact for submissions to all notified bodies Manage all communications, meeting scheduling, meeting materials and meeting minutes with the FDA and other agencies including requests for meetings, advice, etc. Draft and formulate pre-sub and submission packages/dossiers, which include technical documents and data, e.g. assay validation protocols and reports, clinical reports/data and/or other development documentation. Develop, draft and author regulatory submission documentation, including traditional 510K, de-novo 510K, SRDs, IDEs, and PMAs. Develop regulatory strategies alongside the CSO Act as the lead Regulatory personnel represent Qualifications: 6+ years of experience in IVD Regulatory Affairs Preferred experienced with LDTs Ideally experienced with oncology molecular tests, e.g. NGS, multiplex PCR, etc. Successfully authored and files 510k, de-novo 510/PMA, BTD submissions Hands on experience coordinating FDA procedures: planning FDA meetings, leading FDA meetings, taking notes for FDA meetings, etc. International IVD experience Robust understanding of LDT under CLIA/CAP, NYSDOH, and the FDA LDT Final Rule released May 2024.
US$160000 - US$200000 per annum
Connecticut
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Regulatory Affairs Manager
EPM Scientific are currently working with a biotech with an exciting pipeline, who are urgently seeking a Regulatory Affairs Manager to join their team. See a short summary below; Employment Conditions: - Start date: ASAP - Location: Israel - Language: English is essential, additional languages are a plus Key Responsibilities: - Preparing and submitting New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs) along with Investigational New Drug (IND) applications and Clinical Trial Authorizations (CTAs) - Supporting regulatory aspects of clinical trial planning and maintenance. - Engaging with regulatory authorities such as the FDA, EMA, Health Canada, and others. Requirements: - Strong (5+ years preferred) experience in Regulatory Affairs - Experience working in start-up environments is a plus - Exceptional written and verbal communication skills. If this role is of interest to you, please apply directly to learn more about the role. If not feel free to share with your network.
Negotiable
ืึดืฉึฐืืจึธืึตืโ
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Vice President Regulatory Affairs
Title: Vice President Regulatory Affairs An exciting pharmaceutical company is seeking a VP Regulatory Affairs to join the team in making on a meaningful impact on the lives of patients through innovative healthcare solutions. This mid-sized company currently has multiple already approved products with a strong pipeline on the way. This is an opportunity to have a hands on role in guiding the regulatory strategy for cutting edge therapies in the rare disease space. Responsibilities: Collaborate with cross-functional teams, including clinical, commercial, and medical affairs, to develop and implement global regulatory affairs strategies across a product portfolio. Oversee the development and continuous refinement of regulatory policies, procedures, and standard operating procedures (SOPs). Partner with commercial, clinical development, and medical affairs teams to design and implement launch strategies, tactics, and lifecycle management plans. Conduct regulatory assessments to identify product opportunities, risks, and potential challenges. Provide regulatory expertise in the development and approval of promotional materials and marketing campaigns. Work closely with legal, commercial, and clinical teams to develop and review product labeling, advertising, and promotional materials to ensure compliance with regulations. Lead, mentor, and manage the regulatory affairs team, fostering a culture of compliance and high performance. Develop and enhance organizational policies and procedures for regulatory affairs and compliance. Anticipate global regulatory changes and proactively adapt strategies to address them. Provide strategic guidance on all aspects of regulatory requirements in drug development. Interpret communications and decisions from regulatory bodies such as the FDA and international health authorities, developing strategies to resolve issues effectively. Draft, review, and submit responses and documentation to regulatory agencies, ensuring compliance with submission requirements. Communicate with regulatory agencies regarding submission strategies, regulatory pathways, and follow-up actions. Design innovative regulatory strategies for label enhancements and lifecycle product management. Advise senior management on the status of global regulatory strategies, tactics, and risk assessments related to regulatory filings. Review and approve external communications, advertising, and promotional labeling to ensure compliance with corporate policies and applicable laws. Oversee project planning, ensuring priorities are set and key milestones are met in a timely manner. Manage collaborations with contract research organizations (CROs) or external partners, ensuring global submissions align with regulatory requirements. Maintain up-to-date knowledge of the global regulatory landscape, competitive trends, and regulatory guidelines. Establish and direct global benefit-risk strategies for products at all stages of development, including pre-market, post-market, and lifecycle management. Perform other duties as necessary, depending on organizational needs. Qualifications Bachelor's degree in a scientific discipline (advanced degree such as Ph.D. or PharmD preferred) 15+ years of experience in Regulatory Affairs within the pharmaceutical or biotech industries Must have experience in the rare disease space Demonstrated ability to design and implement regulatory strategies for innovative products. In-depth understanding of FDA regulations, ICH guidelines, and the drug development process. Experience preparing regulatory submissions, including INDs and clinical trial documents. Prior experience with clinical trials and regulatory documentation is required. Experience with inhalation products, biologics, or related areas is preferred. Comfortable working in a fast-paced, high-visibility environment with evolving priorities. Willingness to travel up to 15%
US$290000 - US$365000 per annum
Boston
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Labelling Specialist
Job Title: Labelling Specialist - Exciting Freelance Opportunity in Medical Device Sector Location: Germany (Remote/On-site) Leading medical device company committed to improving patient outcomes through innovative solutions. their products, including Class II medical devices, are used globally, and we are dedicated to maintaining the highest standards of quality and compliance. Job Description: We are seeking multiple Relabelling Specialists to join our team on a contract/freelance basis. The successful candidates will be responsible for ensuring that our medical devices meet all regulatory requirements for labelling in various markets. Key Responsibilities: -Review and update labels to comply with local regulatory requirements. -Coordinate with regulatory affairs and quality assurance teams to ensure accuracy and compliance. -Translate and adapt labelling content for different languages and regions. -Manage documentation and maintain records of all labelling changes. -Ensure timely implementation of new labels and packaging. -Conduct quality checks to verify the accuracy of labels. -Communicate with external partners and suppliers regarding labelling requirements. Qualifications: -Bachelor's degree in a related field (e.g., Life Sciences, Regulatory Affairs, Quality Assurance). -Experience in medical device labelling and regulatory compliance. -Knowledge of EU regulations. -Strong attention to detail and organisational skills. -Proficiency in German and English; additional languages are a plus. -Ability to work independently and manage multiple projects simultaneously. -Excellent communication and teamwork skills. Contract Details: Type: Contract/Freelance Duration: 12 months Hours: Full-time
Negotiable
Germany
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Global Regulatory Specialist
Here is your chance to join an innovative and cutting-edge medical device company! The company I am supporting has innovated and launched over 100 products and doesn't plan on slowing down any time soon. This company dominates the market share, and its products can be found in over 50 countries. With a large emphasis on providing honest and real messaging across their products, this company truly cares and invests in their customers. As a Global Regulatory Specialist, you will be joining an exciting and growing Quality and Regulatory team. They are looking for someone who has knowledge of FDA, GxP and CPSC regulations. In addition, as the Global Regulatory Specialist, you will need to navigate the regulations of global health authorities. In this role you will cultivate the skills to manage regulatory responsibilities connected to product development and aid the manufacturing of the company's medical device, OTC and general use products. Key Responsibilities: Oversee the development and execution of regulatory strategies to ensure timely product launches and manage the preparation and review of international regulatory submissions, including EU MDR Technical Files, Health Canada submissions, and Saudi FDA documentation. Act as a representative for international regulatory interests within cross-functional project teams for both new and existing products. Review and approve global labeling requirements, including translation materials, claims, and instructions for use (IFU). Assess proposed changes for their impact on international regulatory compliance. Facilitate clear communication within the Regulatory Affairs/Quality Assurance (RA/QA) group and collaborate with cross-functional teams such as Product Development, Marketing, and Legal. Support efforts to maintain ISO 13485 and MDSAP certifications through activities such as internal audits, notified body audits, and SOP compliance. Qualifications A bachelor's degree in Science, Engineering, or Pharmaceutical disciplines. Proven experience in international regulatory affairs, including submissions, license renewals, and technical file management. At least three years of experience in a medical device, pharmaceutical, or similar industry. Strong organizational skills with the ability to manage multiple priorities and meet deadlines. Meticulous attention to detail and a highly organized approach to tasks. Ability to work both independently and collaboratively within teams. Results-driven, innovative, and skilled at multitasking. Familiarity with 21 CFR 820, ISO 13485, MDSAP, the Medical Devices Directive (93/42/EEC), and the European Medical Device Regulation (2017/745).
Negotiable
Florida
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Global Regulatory Specialist
Here is your chance to join an innovative and cutting-edge medical device company! The company I am supporting has innovated and launched over 100 products and doesn't plan on slowing down any time soon. This company dominates the market share, and its products can be found in over 50 countries. With a large emphasis on providing honest and real messaging across their products, this company truly cares and invests in their customers. As a Global Regulatory Specialist, you will be joining an exciting and growing Quality and Regulatory team. They are looking for someone who has knowledge of FDA, GxP and CPSC regulations. In addition, as the Global Regulatory Specialist, you will need to navigate the regulations of global health authorities. In this role you will cultivate the skills to manage regulatory responsibilities connected to product development and aid the manufacturing of the company's medical device, OTC and general use products. Key Responsibilities: Oversee the development and execution of regulatory strategies to ensure timely product launches and manage the preparation and review of international regulatory submissions, including EU MDR Technical Files, Health Canada submissions, and Saudi FDA documentation. Act as a representative for international regulatory interests within cross-functional project teams for both new and existing products. Review and approve global labelling requirements, including translation materials, claims, and instructions for use (IFU). Assess proposed changes for their impact on international regulatory compliance. Facilitate clear communication within the Regulatory Affairs/Quality Assurance (RA/QA) group and collaborate with cross-functional teams such as Product Development, Marketing, and Legal. Support efforts to maintain ISO 13485 and MDSAP certifications through activities such as internal audits, notified body audits, and SOP compliance. Qualifications A bachelor's degree in Science, Engineering, or Pharmaceutical disciplines. Proven experience in international regulatory affairs, including submissions, license renewals, and technical file management. At least three years of experience in a medical device, pharmaceutical, or similar industry. Strong organizational skills with the ability to manage multiple priorities and meet deadlines. Meticulous attention to detail and a highly organized approach to tasks. Ability to work both independently and collaboratively within teams. Results-driven, innovative, and skilled at multitasking. Familiarity with 21 CFR 820, ISO 13485, MDSAP, the Medical Devices Directive (93/42/EEC), and the European Medical Device Regulation (2017/745).
Negotiable
United States of America
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Director Regulatory Affairs
Director of Regulatory Affairs Strategy This position is with a rapidly growing pharmaceutical company known for its commitment to advancing transformative therapies. In this role you will have a unique opportunity to lead regulatory strategies for innovative pharmaceutical products, making a meaningful impact on patient health. You'll collaborate with cross-functional teams and engage directly with regulatory agencies, influencing critical decisions in drug development. Key Responsibilities: Oversee daily regulatory activities for projects involving compounds in development or on the market, including submission strategies and regulatory intelligence. Collaborate with Project Teams to develop regulatory and product strategies, including drafting labeling and NDA package inserts. Work with various departments to formulate and execute effective Regulatory Strategies, assessing and communicating regulatory risks and opportunities. Manage submissions and maintenance of INDs, NDAs, MAAs, and related documents. Support due diligence activities for potential product acquisitions or partnerships. Serve as the primary regulatory contact with agencies, including the FDA, and represent the regulatory function in key meetings. Monitor the regulatory landscape and communicate updates to stakeholders. Advise on regulatory requirements to support business strategies, providing expert guidance on scientific and medical issues. Qualifications: Bachelor's degree in life sciences or related field; advanced degree preferred. Minimum 10 years of experience in pharmaceutical regulatory drug development. Proven track record in new chemical entity and line extension filings. Experience interacting with global health authorities and conducting due diligence. Strong knowledge of global pharmaceutical regulations and excellent communication skills.
Up to US$225000 per annum
Philadelphia
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Director Regulatory Operations
A growing biotech is seeking a Director of Regulatory Operations to play a pivotal role in overseeing the regulatory strategy and operations for the company's global submissions and systems projects in a dynamic and rapidly evolving environment. This company is focused on developing innovative therapies for rare and undeserved diseases, with a strong emphasis on using cutting-edge science to target key biological pathways for genetic conditions. This role requires strong leadership in regulatory operations, ensuring efficient submission processes and compliance while fostering collaboration across cross-functional teams. Responsibilities Provide regulatory operations expertise and leadership to cross-functional teams supporting the pipeline, train and lead regulatory operations personnel reporting into this role. Lead the development, refinement, and implementation of internal processes, procedures, work instructions, and training programs for submission production and operational support activities. As needed, train colleagues and project teams. Oversee full implementation, maintenance & optimization of a Regulatory Information Management (RIM) system. Provide RIM system leadership by overseeing the development of RIM projects based on current and future business needs, optimizing the use of system attributes. Oversee and manage all global regulatory submissions, systems-related projects, and submission compliance. Oversee management of external publishing vendors. Ensure proper maintenance of regulatory submissions filing, Health Authority correspondence logs, and archival of previous regulatory submissions. Oversee the build of submission binders & content plans for future regulatory submissions globally. Stay current with regulatory requirements and industry best practices. Prepare and present regulatory reports, metrics, and dashboards. Lead budgeting and forecasting activities for the Global Reg Ops function, including managing vendors. Requirements Bachelor's Degree in life sciences or a related field 8+ years of Regulatory Operations experience in pharma/biotech NDA/MAA filing experience. Expert knowledge of regulatory submission publishing standards and procedures, including computer word processing and electronic document management systems. Understanding of drug development and business processes. Knowledge and experience of eCTD submissions. Knowledge of FDA, EMA, and ICH guidelines. Proven internal and external leadership with the ability to work cross-functionally and globally. Ability to work independently and successfully in a matrix environment, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues, and balance competing priorities effectively. Extensive knowledge in the implementation of GxP Systems (e.g., Document Management Systems) and formatting solutions (e.g., authoring templates). Comfortable in a small company environment that is fast-paced, challenging, and take a hands-on approach to get results.
US$180000 - US$220000 per annum
Massachusetts
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Regulatory Affairs Manager
ABOUT: Are you passionate about advancing treatments for life-changing conditions? This global specialty pharmaceutical leader is transforming the landscape of genetic, metabolic, and systemic disorders. With a cutting-edge focus on melanocortin technology, they are on a mission to build a world-class melanocortin house-bringing hope to patients with life-threatening and acute conditions. With 10 products in the pipeline, ranging from pre-clinical to commercial, the company is looking to bring on a Regulatory Manager to their US site (California; However, this role can be remote)*. Key Responsibilities: Assist in the development of the ongoing global regulatory strategy Submissions of NDAs and amendments Applications and submissions to the FDA as required following post approval obligations and commitments, as well as prepare response to questions raised by FDA Maintain all approvals by submitting annual updates as needed (example Orphan designations, Investigator Brochure) Support Quality and Pharmacovigilance colleagues in systems management Prepare and/or collate all documentation to support clinical trial applications Assist sites in submitting applications to IRBs, and preparing responses to questions raised by IRBs and updated documentation as required Ensure investigation medicinal product is supplied to the study sites in compliance with all regulatory requirements, including packaging Manage packaging material manufacturing and create secondary packaging material Review and approve contract manufacturer's specifications and packaging documents Qualifications: Minimum 5 years pharmaceutical industry experience Proven experience in preparation of New Drug Applications Proven experience in regulatory management of centrally approved products Understanding of Orphan Drug requirements Proven understanding of eCTD Modules 1-5 Preparation of marketing authorization applications in eCTD format Proven experience in labelling, pricing and reimbursement procedures (desirable) Preparation of CTAs to support clinical trials (desirable)
Negotiable
San Francisco
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