Regulatory

Regulatory

At any time, there are more than300,000 clinical studieshappening around the world. The process for bringing new pharmaceuticals to the market is prolonged due to regulation placed on the drugs sector in order to protect public safety.The Federal Institute for Drugs and Medical Devices(Bundesinstitut für Arzneimittel und Medizinprodukte or BfArM) is the legal narcotics and medical device regulatory authority in Germany. According to the BfArM, “They are involved in the tasks of licensing, improving the safety of medicinal products, detecting and evaluating the risks of medical devices, and monitoring the legal traffic in narcotic drugs and precursors.”

The effects of Brexit are being felt across many different industries in Germany, particularly in the pharma regulatory sector. The BfArM is one of the major licensing authorities in the EU and actively supports theEuropean Medicines Agencyin all key areas of drug authorisation and drug safety, together with thePaul Ehrlich institute, more than480 experts bring their expertise to around 130 scientific bodiesof the EMA.

According toProf. Dr Karl Broich, President of the BfArM, “The organisation makes significant contributions to the supply of patients in Europe with safe medications and will increase these contributions in the years to come after Brexit and the loss of the British licensing authority, the number of authorisation processes will also increase, for Germany in particular.”

Increased demand for regulation following Brexit will likely see substantial growth in the market over the next number of years. At the moment theBfArM employs roughly 1,100 employeesacross many different specialisms including physicians, pharmacists, chemists, biologists, lawyers, engineers, technical assistants, administrative staff. More than 130 of their nearly 1,100 employees will reach the age of 65 within the next 5 years, in other words, 12 % of the staff will retire in the near future. This will free up numerous jobs that will need to be filled as Europe becomes more reliant on Germany to spearhead regulation following the UK’s exit of the EU.

EPM Scientific is a global specialist recruitment company working exclusively in the Life Sciences industry. Our expert consultants place talent in the regulatory industry in Germany and across Europe.


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Regulatory Jobs

Senior Regulatory Affairs Specialist

We are currently seeking a Senior Regulatory Affairs Specialist for our client, a leading medical device company in Irvine, California. The successful candidate will be responsible for providing regulatory guidance to cross-functional teams, managing regulatory submissions, and ensuring compliance with all applicable regulations. Responsibilities: - Managing regulatory submissions for US and EU Class I, II, and III medical devices - Conducting regulatory assessments of medical device design and manufacturing changes - Ensuring compliance with all applicable US and EU medical device regulations - Providing regulatory guidance to cross-functional teams - Participating in product development teams to ensure regulatory compliance throughout the product lifecycle - Developing and maintaining regulatory strategies to support product development and commercialization - Interacting with regulatory agencies as needed - Keeping up-to-date with changes to US and EU medical device regulations Skills: - Strong knowledge of US and EU medical device regulations - Experience with US and EU medical device regulatory submissions - Experience with life cycle management of medical devices - Strong communication and interpersonal skills - Ability to work independently and as part of a team - Strong analytical and problem-solving skills - Attention to detail - Ability to manage multiple projects simultaneously

Negotiable
Irvine
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Senior Research Associate, Cancer Biology

**Onsite Role in South SF, CA** Job opportunity with a top Biotech/Pharmaceutical company that is looking for a Senior Research Associate, Cancer Biology to join their team on a 12-month contract with an opportunity for conversion or extension! Qualifications: A minimum of a B.S. degree in cancer/cell/molecular biology or related area with 2-3 years of experience in cancer biology or M.S degree with 1-2 years in cancer/cell/molecular biology or related area; biotech and/or pharmaceutical industry experience is a plus Expertise in mammalian cell culture using aseptic tissue culture techniques and cell-based assays to evaluate viability (siRNA/shRNA, small molecule compound screening), protein analysis (western blot), gene expression analysis (qRT-PCR) and other functional/molecular biology assays. Job Description/Skills: Design research experiments and work independently to execute experiments Perform in vitro cellular assays to profile compounds, to enable mechanism of action studies for potential anti-cancer therapeutics and to validate new targets using genetic and pharmacological tools Generate engineered cell lines for screening assays Maintain and culture tumor and non-tumorigenic cell lines Analyze, interpret scientific data and build data decks in PowerPoint Troubleshoot assays to ensure high quality data Interface closely with scientists in the research group and project team to ensure efforts are aligned to the scientific project goals Benefits/Perks: 401k Health Insurance Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?

US$50 - US$55 per hour
San Francisco
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Regulatory Affairs Labeling Lead

Regulatory Affairs Labeling Lead Company Summary: My client is a leading generic pharmaceutical company focused on delivering medicines for cardiovascular diseases, oncology, metabolic diseases, anti-infective, infusion and pain management. They are looking for a Regulatory Labeling Lead to join the team, reporting 3 days per week onsite in East Brunswick, New Jersey. The Regulatory Affairs Labeling Lead will be responsible for: Preparing, reviewing, and approving pharmaceutical labeling for generic drug products including container labels, cartons, package insert, medication guides, etc. Creating draft labeling for new generic drugs for submission in ANDAs to the FDA. Ensuring labeling meets FDA requirements and internal timelines. The Regulatory Affairs Labeling Lead should have the following qualifications: 2+ years Regulatory Affairs Labeling experience. Generic drug labeling experience required. Knowledgeable in FDA Labeling requirements

Negotiable
East Brunswick
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Director Regulatory Affairs

Global Director Regulatory Affairs (Bilingual Chinese) Company Summary: My client is a global biopharmaceutical company focusing on developing treatments for autoimmune, oncology and ophthalmic diseases with unmet needs. They are looking to add a fully remote Global Director of Regulatory Affairs who is fluent in both English and Chinese Mandarin. The Regulatory Affairs Director will be responsible for: Representing regulatory affairs in project meetings and in the preparation of regulatory documents. Serving as the internal expert in international RA by providing guidance to management and project teams for international registration of new products/indications for the US, EU, and Australia. Organizing FDA communication meetings and providing interpretation of regulations and interactions with agencies (FDA, EU, etc). The Regulatory Affairs Director should have the following qualifications: 10+ years of Regulatory/industry experience in biotech/pharmaceuticals. Bilingual in both English and Chinese Mandarin. 8+ years as the Global Regulatory Lead representative on project development teams.

Negotiable
Rockville
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Regulatory Affairs Consultant

**Hybrid Role in Somerset, NJ** Job opportunity with a top Biotech/Pharmaceutical company that is looking for a Sr. Consultant Regulatory Affairs to join their team on a 12-month contract with an opportunity for conversion or extension! Qualifications: Bachelor or Master's Degree in a scientific area (Degree in Pharmacy/Regulatory Affairs is preferred) 2-3 years' experience in the pharmaceutical industry. Experience focused on generics. Job Description/Skills: Independently manage the planning, authoring, review, compilation, organization, and preparation of Chemistry, Manufacturing, and Controls (CMC)/Technical data for high-quality registration submissions, such as ANDAs, INDs, NDAs Amendments, Supplements, and Annual Reports Prepare, develop, and define timelines for FDA responses to queries and ensure the issues are addressed in a complete and timely manner Provide CMC strategy and raise key issues throughout the lifecycle of products in a timely manner to project teams and management. Review ANDAs, supplements, and amendments and highlight any major gaps in the submission documents Creation and Maintenance of Drug product labeling including track of RLD labeling updates creation and drug listing activities. Preparation and submission of Labeling Supplements, Annual Reports, and other administrative FDA correspondences. Independently review, compile, and submit high-quality controlled correspondences and meeting requests Initiated, evaluated and approves change controls (as needed) in accordance with FDA and ICH guidelines Benefits/Perks: 401k Health Insurance Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?

US$45 - US$50 per hour
New Jersey
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Head of Regulatory affairs

We are looking for a Head of Regulatory Affairs to manage a team of regulatory affairs professionals for a leading medical device company in Germany. The ideal candidate will have a minimum of 5 years experience in regulatory affairs in the medical device industry. Responsibilities - Develop, implement and manage regulatory strategies for Class I, IIa and IIb medical devices - Ensure regulatory compliance with MDR and other applicable regulations - Manage the preparation and submission of regulatory filings - Provide guidance and support to cross-functional teams on regulatory requirements - Manage a team of regulatory affairs professionals - Develop and maintain strong relationships with regulatory authorities Skills - Minimum 5 years experience in medical device regulatory affairs - Experience with Class I, IIa and IIb medical devices - MDR experience - QMS experience would be an advantage - Strong leadership and communication skills - Ability to work collaboratively with cross-functional teams Benefits - Extremely competitive salary with additional benefits - Opportunity to work for a leading medical device company in Germany - Manage a team of highly talented regulatory affairs professionals

Negotiable
Deutschlandsberg
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Senior regulatory affairs specialist

Senior Regulatory Affairs Specialist We are currently seeking a Senior Regulatory Affairs Specialist to join our client's team in Jena, Germany. Our client is a leading medical device company dedicated to improving health-care through innovative products. The successful candidate will work closely with the regulatory affairs team to ensure that all products meet the regulatory requirements for the global market. Responsibilities The Senior Regulatory Affairs Specialist will be responsible for the following: - Ensuring that all products meet the regulatory requirements for the global market - Developing and implementing regulatory strategies for new and existing products - Collaborating with cross-functional teams to ensure that products are developed in compliance with regulatory requirements - Preparing and submitting regulatory submissions to regulatory agencies - Reviewing and approving labelling, advertising, and promotional materials - Maintaining up-to-date knowledge of regulatory requirements and changes - Providing regulatory guidance to cross-functional teams - Representing the company in interactions with regulatory agencies Required Skills The successful candidate will have the following skills: - Strong multitasking skills - Ability to handle complexity - Process driven - Experience writing SOP's - Strong communication and interpersonal skills - Ability to collaborate with cross-functional teams - Fluent in German - B1 minimum - Medical device, Pharma or IVD experience Qualifications The ideal candidate will have: - 2-3 years working experience - PHD is preferred - Knowledge of global requirements is crucial

Negotiable
Germany
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Regulatory affairs Team Lead

This is an opportunity to join a leading Medical Device manufacturer that is looking to expand their talent within Switzerland with a real focus on Regulatory activities. You would be joining a dynamic team of both Regulatory and Quality talent located in Switzerland Responsibilities: Help us to get our innovative medical devices approved quickly and safely and to master regulatory challenges over the long term. Leading a team of four employees Define regulatory strategy and requirements in support to new product introduction and life-cycle management projects Checking the completeness and correctness of project documentation/test reports from a regulatory point of view Communication with external parties e.g. certified and notified body Preparation and maintenance of the Technical Documentation (EU/MDR) Submission and maintenance of approvals in Europe, USA and Canada Evaluation of substantial changes on existing approvals Support for the team Regulatory International for other international approvals Participation in reviews of product labelling documentation (manuals, brochures, websites, etc.) Collaboration in the implementation of new standards and regulations Preparation and maintenance of various regulatory overviews and training for other departments Qualifications: 5 year's in regulatory affairs (Medical Device) Leadership skills and team oriented Strong communicator Experience with approvals under MDR and preparation of technical documentation Experience with international approvals (e.g. FDA) Fluent in English and German

Negotiable
Switzerland
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Regulatory Affairs Team Lead

This is an opportunity to join a leading Medical Device manufacturer that is looking to expand their talent within Switzerland with a real focus on Regulatory activities. You would be joining a dynamic team of both Regulatory and Quality talent located in Switzerland Responsibilities: Help us to get our innovative medical devices approved quickly and safely and to master regulatory challenges over the long term. Leading a team of four employees Define regulatory strategy and requirements in support to new product introduction and life-cycle management projects Checking the completeness and correctness of project documentation/test reports from a regulatory point of view Communication with external parties e.g. certified and notified body Preparation and maintenance of the Technical Documentation (EU/MDR) Submission and maintenance of approvals in Europe, USA and Canada Evaluation of substantial changes on existing approvals Support for the team Regulatory International for other international approvals Participation in reviews of product labelling documentation (manuals, brochures, websites, etc.) Collaboration in the implementation of new standards and regulations Preparation and maintenance of various regulatory overviews and training for other departments Qualifications: 5 year's in regulatory affairs (Medical Device) Leadership skills and team oriented Strong communicator Experience with approvals under MDR and preparation of technical documentation Experience with international approvals (e.g. FDA) Fluent in English and German

Negotiable
Schweizer-Reneke
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Quality assurance & Regulatory affairs

Global leader in medical technology (radiation therapy and X-ray diagnostics. Innovation, quality and customer focus make us a trendsetter in the industry. Our approximately 200 highly qualified employees work at our HQ in Germany and in our subsidiaries globally Tasks Preparation, implementation and support of global regulatory product approvals and registrations Creation of approval dossiers and documentation for new products, taking into account the relevant regulations and standards. Supporting development teams in ensuring compliance with relevant standards. Support for engineering and service in all questions relating to quality. Support with product and process improvements. Maintenance and further development of the QM system. qualification Ideally, you have a master's degree in a technical or scientific field or comparable training. 3 - 5 years of professional experience in quality management and/or regulatory affairs in a medical technology company Experience with international regulations is advantageous (China, India, US, Canada) You have a good technical understanding and ideally already experience with active medical devices and/or SamD You are reliable and have an analytical, systematic and independent way of working. You are a team player and have very good communication skills Both written and spoken German and English to a business professional standard

Negotiable
Nürnberger Land
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Senior Director - Global Regulatory Affairs CMC

Senior Director - Regulatory Affairs CMC Small Molecule We are currently looking for a Senior Director of Global Regulatory Affairs (GRA) CMC for a client in the pharmaceutical industry. The successful candidate will be responsible for the early development of small molecule drugs and will be based in Boston, Massachusetts. Candidate must be able to go on-site. Responsibilities - Oversee and lead the development of global regulatory CMC strategies for small molecule drugs - Collaborate with cross-functional teams to ensure that regulatory CMC requirements are met - Provide technical expertise and guidance to ensure that regulatory CMC strategies are in line with global regulatory guidelines - Ensure that regulatory CMC submissions are of high quality and are submitted on time - Build and maintain strong relationships with regulatory authorities Skills - Extensive experience in early development of small molecule drugs - Strong knowledge of global regulatory CMC guidelines - Excellent leadership and communication skills - Ability to work collaboratively with cross-functional teams Additional Information - Small molecule experience is required - 15 years of experience in pharmaceutical and global health authority experience - Extensive early development experience is required - Management experience

Negotiable
Boston
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Senior Director - Global Regulatory Affairs CMC

Senior Director, Global Regulatory Affairs CMC Company Summary: My client is a large, global leader in the pharmaceutical industry committed to delivering life changing treatments for diseases of many different therapeutic areas including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. They are looking to add a Senior Director, Global Regulatory Affairs CMC to their team. This position will report into the Boston office 5 days per month. The Regulatory Affairs CMC Senior Director will be responsible for: Serving as a member of the GRA-CMC Pharmaceutical Leadership team and establishing a CMC RA strategy. Providing leadership of early development pharmaceuticals and in conjunction with direct reports to develop high quality clinical submissions. Building and maintaining relationships with key internal (GRA, GRA CMC, Pharmaceutical sciences, etc.) and external (health authorities, industry counterparts/associations) stakeholders. The Regulatory Affairs CMC Senior Director should have the following qualifications: At least 15 years of Regulatory experience in pharmaceutical industry. Experience working with international regulations and major regulatory agencies (i.e. US FDA, EU, PMDA, NMPA, WHO).

Negotiable
Boston
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