Associate Director Regulatory Affairs
My client develops, manufactures, and markets innovative life-enhancing cell therapies. This company has three approved products and they recently received a Regenerative Medicine Advanced Therapy designation for one of their development programs. They are seeking a Regulatory Affairs Associate Director to develop clinical regulatory strategies and provide post-market support. You will be the primary interface with the FDA for assigned programs and will contribute significantly to an upcoming BLA. Now is the time to join this growing company and advance your career!
Responsibilities:
- Develop, lead, and execute regulatory strategies for development programs
- Be the primary contact with the FDA for clinical regulatory activities
- Oversee the preparation, review, and submission of regulatory applications
- Support and manage preparation of FDA meeting requests and briefing documents
- Manage and ensure compliance with all reporting requirements, including annual and periodic reports
- Provide strategic guidance for and author applications related to designations for expedited programs (e.g. Fast Track, Breakthrough, Priority) or special status (e.g. Orphan).
- Manage contract staff and vendors as needed to support regulatory activities.
- Provide create and innovative solutions while being an advocate for compliance.
- Perform other duties as required, interfacing with other departments, CROs and external vendors as needed.
Knowledge and Skills:
- BA/BS degree in a scientific disciple required. An advanced degree (MS or PhD) is preferred
- Minimum of 7 years of experience in Regulatory Affairs strategy for pharmaceuticals or biotech products
- Prior experience managing and preparing INDs, NDAs, and/or BLAs
- Strong knowledge of eCTD elements and structure
- Prior interaction experience with the FDA including onsite meetings
- Global regulatory experience a plus
- Regulatory strategy experience with both development and commercial products.
- Strong writing skills, verbal communication, and attention to detail
- Experience working with all levels of management and consulting with key business stakeholders
- Ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.