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We're looking for an Associate Director Regulatory Affairs CMC
, working in Pharmaceuticals and Medical Products
industry in Cambridge, Massachusetts, United States
- Leads development and execution of robust global regulatory CMC strategy for assigned program(s) with balanced risk-based approach using scientific rationale and in alignment with regulatory guidance,working in collaboration with cross-functional CMC and Global Regulatory Teams to achieve program and company goals.
- Leads preparation, including driving strategy and content of high quality regulatory submission content focusing on chemistry, manufacturing, and control (CMC) to support global clinical development, registration, and product life cycle management
- Manages timely regulatory submissions that involve CMC components including CTAs/INDs, NDA/MAA, and agency meeting packages.
- Provides support to regulatory interactions on CMC related topics.
- Actively participates in RA CMC infra-structure and capability.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- Minimum 8 years of experience in the pharmaceutical/biotechnology/life science industry, including at least 5 years regulatory affairs experience including managing submissions and developing regulatory CMC strategy for development and/or commercial pharmaceutical or biological products
- Sound understanding of chemistry and biology
- Direct experience in preparation of original NDA/BLA, response to regulatory agency queries, and/or other complex submissions
- Experience in oligonucleotides is a plus
- BS in science related field required, MS/PhD preferred
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?