Senior Director, Regulatory Affairs CMC

Role Summary

Senior Director, Regulatory Affairs CMC is 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 role provides regulatory leadership and urgency to cross-functional teams responsible for global programs and ensures effective communication with business partners and health authorities worldwide regarding all aspects of regulatory CMC. Strong background in working with biologic assets is required. This role is based in Lexington, MA with a hybrid schedule of 4 days in the office and 1 day remote.

Responsibilities

• Provide regulatory CMC strategic leadership for drug development projects and life cycle management, including health authority interactions, regulatory submissions, and other regulatory requirements in line with corporate objectives and timelines
• Serve as a spokesperson with 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
• Lead 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 to execute program objectives in compliance with applicable regulations
• Contribute to strategic leadership and development of policies, procedures, and best practices for a rapidly growing company

Qualifications

• Requires a Master’s Degree (PharmD or PhD preferred) with 10+ years of experience in regulatory affairs within the biopharmaceutical 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 is desired; experience with both early and late-stage drug development and life cycle management is 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
• Experience interacting directly with the FDA and other health authorities
• Strong leadership and communication skills and experience working with multiple functional areas in a matrixed team environment
• 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