Senior Director, Regulatory Affairs CMC
About The Position
Reporting to the SVP of Global Regulatory Affairs, the Sr. Director, Regulatory Affairs CMC will be responsible for developing and implementing regulatory CMC strategy leading to successful registration and life-cycle management of unique products serving patients with unmet medical needs. This individual will provide regulatory leadership and a sense of urgency to cross-functional teams responsible for global programs and ensure effective communication with business partners and representatives of the US Food and Drug Administration and Health Authorities worldwide with regard to all aspects of regulatory CMC. Strong background in working with biologic assets is required. This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
Requirements
- Requires a Master’s Degree (PharmD, or PhD preferred) with 10+ years of experience in regulatory affairs within the bio pharmaceutical industry
- Strong knowledge of FDA regulations and EU CTA/CTR requirements
- Prior experience with biologics drug development/monoclonal antibodies is strongly desired
- Prior experience and success with filing original BLAs/MAAs desired.
- Experience with both early and late-stage drug development, and life cycle management desired.
- Experience with tech transfers/manufacturing transfers desired
- Comfortable with setting strategies as well as taking a hands-on approach to CMC regulatory activities
- Experience with preparing CMC regulatory documents including new INDs, IND amendments, annual reports, briefing packages and other regulatory submissions required
- Experience interacting directly with the FDA and other health authorities desired
- Strong leadership and communication skills and experience in working with multiple functional areas in a matrixed team environment required
- Strategic thinker who can balance near term objectives with long term goals and outcomes
- Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience
- Ability to thrive in a collaborative and fast-paced team environment
Responsibilities
- Provide regulatory CMC strategic leadership for drug development projects and life cycle management, including but not limited, to health authority interactions, regulatory submissions and other regulatory requirements in line with corporate objectives and timelines
- Serve as a well-respected spokesperson with staff at FDA and other Health Authorities to present and negotiate on CMC issues
- Provide de-risking CMC development strategies, assessing change controls and evaluating opportunities to accelerate development in a fast-paced environment
- Provide leadership, and contribute hands on support to the regulatory and manufacturing team in managing, planning, coordinating, and preparing all CMC documents submitted to FDA and ex-US health authorities in support of INDs, BLAs, MAAs, DMFs, CTRs/IMPDs, amendments, and annual updates
- Interpret and communicate regulatory CMC expectations to internal and external stakeholders in order to execute program objectives in compliance with applicable regulations
- Contribute to the strategic leadership and development of policies, procedures and best practices commensurate with the requirements of a rapidly growing company
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
251-500 employees
