Job Description:
Seeking a highly experienced and motivated individual to join an innovative team as a Senior Director, Regulatory Strategy. As a member of this global biopharmaceutical company, you will be responsible for developing and implementing regulatory strategies for multiple programs in various stages of clinical development, as well as leading a team of multiple direct reports. This will be working on a range of innovative novel drugs in immunology, oncology and neurology. This will report directly into the VP of Regulatory Affairs.
Key Responsibilities:
- Develop and implement regulatory strategies for company products in collaboration with cross-functional teams, including clinical development, medical affairs, and commercial teams.
- Provide regulatory guidance to cross-functional teams throughout the product development lifecycle, from pre-clinical development through post-marketing activities.
- Act as the key point of contact for external regulatory agencies and Health Authorities.
- Lead the regulatory team to ensure timely and successful regulatory submissions, including INDs, NDAs, and BLAs.
- Keep up-to-date with changes to relevant global regulations and guidelines and assess the potential impact on company programs.
- Work with cross-functional teams to develop risk management plans and contingency plans to mitigate potential regulatory issues.
- Manage a team of regulatory professionals, providing guidance and mentorship to ensure regulatory compliance and success.
Qualifications:
- BSc required, with a preference for an advanced degree in a scientific field, such as biology, chemistry, or pharmacology.
- At least 10 years of experience in regulatory affairs in the biopharmaceutical industry, with a focus on branded/novel drug development.
- Proven track record of successful regulatory submissions, including experience with INDs, NDAs, and BLAs.
- Strong knowledge of FDA regulations and guidelines, as well as international regulatory requirements.
- Excellent communication and interpersonal skills, with the ability to build strong relationships with both internal and external stakeholders.
- Strong leadership skills, with experience managing a team of regulatory professionals.
If you are a highly motivated individual with a passion for regulatory strategy and a desire to make a meaningful impact in the biopharmaceutical industry, we encourage you to apply for this exciting opportunity.
