Senior Manager/Associate Director, Regulatory Affairs - CMC
JOB TITLE: Senior Manager/Associate Director, Regulatory Affairs -CMC
REPORTING RELATIONSHIP: Director, Regulatory Affairs - CMC
DATE AVAILABLE: Immediately
LOCATION: Lexington, MA
The successful candidate for this role will be responsible for providing global regulatory support across the Synageva disease/product portfolio. This will include contributing to the definition of CMC requirements for IND/CTAs and marketing application approvals, acting as a supportive RA representative on Technical Operations and Analytical teams, preparing responses to CMC questions arising from competent authority reviews, and contributing to the RA-CMC strategy for global submissions and approvals for our products. His/her specific job responsibilities will include:
- Leading the preparation of the CMC content for clinical trial applications for a pipeline product and acting as the primary RA-CMC representative for that project team.
- Supporting dossier preparation for lead product to assure timely and high-quality submission development.
- Contributing to pre-submission meetings with regulatory authorities to reach agreement on complex CMC requirements for approvals of products.
- Working with Technical Operations, Quality, Analytical and other relevant departments to assure BLA/CTD readiness from a CMC perspective for lead product
- Managing, tracking, and assuring Synageva’s accountability to global regulatory CMC commitments.
Providing RA-CMC support and advice for all internal activities related to manufacturing, development, control, and quality of products in development.
Minimum Job Requirements:
- BA/BS degree in a scientific discipline (advanced degree preferred)
- Minimum of 7 years of experience in Regulatory CMC within the biotechnology/pharmaceutical industry; experience with protein therapeutics or other biological products preferred
- Strong written and verbal communication skills
- Substantial understanding of current state-of-the-art manufacturing, controls, and analytical requirements associated with biologics development and approval
- Experience managing complex CMC submissions to and responding to questions from global regulatory authorities
- Excellent interpersonal skills and proven ability to work as part of an effective team
- Self-motivated and results-oriented with the high energy drive to achieve objectives that support the business