This biotech startup is developing gene therapies for people with rare, devastating diseases. They are seeking a Regulatory Affairs Senior Director who can lead their Regulatory function and file their first IND. You will develop and execute regulatory strategies for AAV gene therapy programs and build out the Regulatory team. This company offers a collaborative company culture along with pre-IPO equity. Now is an exciting time to join this growing organization and help to get innovative therapies approved!
- Lead the Regulatory Affairs function for the organization, including hiring and management of a small team.
- Develop appropriate regulatory strategies for projects in development in collaboration with cross-functional team members.
- Manage the preparation and timely submission of regulatory documents, including an original INDs, CTAs, briefing documents for key meetings, responses to regulatory requests and required periodic reports.
- Work with multidisciplinary team members to ensure the quality, content, timeliness and format of regulatory submissions and amendments comply with all applicable regulations and guidelines for AAV gene therapy products.
- Serve as the primary point of contact for all FDA interactions, including the preparation and regulatory leadership for key meetings including pre-IND, etc.
- Draft and submit applications for designations for expedited programs like Breakthrough Therapy, RMAT or Orphan Drug status.
- Serve as the internal primary conduit on all Regulatory matters for senior leadership. Provide guidance to all appropriate departments to assure compliance with applicable regulations.
- Remain knowledgeable of current regulations and guidance, provide thoughtful interpretation of same and notify appropriate personnel.
- Collaborate with third party regulatory consultants and CROs to supplement expertise and operational capacity, with the ultimate goal of building and staffing a broader regulatory affairs function.
- Serve as the subject matter expert on regulations, guidance documents, contemporary regulatory practices and relevant regulatory precedence to guide the overall development plans accordingly.
- Develop risk assessment scenarios and options for review with multidisciplinary team.
- Develop, review and maintain Regulatory and other applicable SOPs and policies.
- Lead effective management of the department, including budget administration, cost control, etc.
- Bachelor’s degree in a scientific field. Advanced degree, such as PharmD, PhD, MS preferred.
- Ten or more years of experience in Regulatory Affairs for pharmaceutical drugs and/or biologics.
- Must have some regulatory experience with biologic programs. Gene therapy experience a plus, but not required.
- Experience developing and leading regulatory strategies for INDs, CTAs, NDAs, MAAs and/or BLAs with a track record of successful approvals.
- Strong knowledge of biopharmaceutical industry Regulatory Affairs throughout the product lifecycle, including Development, CMC, Labeling, Promotion, Commercialization, and Operations.
- Knowledge of clinical development, including responsibilities for successful management of development milestones and marketing authorization, meeting facilitation, deficiency letter and regulatory responses.
- Knowledge of domestic laws, regulations, and guidance that affect biologic prescription products.
- Experience in a small pharma company environment preferred.
- Previous experience leading and managing a Regulatory team desired.
- Strong interpersonal skills with the ability to negotiate and influence others in a positive and effective manner, with or without direct authority.
- Capacity to react quickly and decisively in unexpected and dynamic situations.
- Ability to lead, provide direction and guidance, make decisions, think critically, solve problems and respond proactively.
- Must have excellent communication skills (both written and oral).
- Strong project management skills required.
Please note that there is no relocation package available for this position and our client is seeking local candidates in the Boston area only.