Director, Regulatory CMC

Third Rock Ventures - Lexington, MA

Full-time

Lexington, MA

Securities, Commodity Contracts, and Other Financial Investments and Related Activities

About the position

The Director, Regulatory CMC will provide regulatory CMC leadership for program teams developing biologic and cell and gene therapy products. This position is responsible for driving global CMC RA strategy and execution, including the generation of quality dossiers to support Health Authority meetings, INDs/CTAs/IMPDs, and marketing applications in collaboration with stakeholders. This position will partner with SMEs across the organization to author and review key regulatory documents, represent the organization at health authority meetings, and help shape the regulatory organization.

Responsibilities

• Oversees, recommends and implements CMC regulatory strategy activities in alignment with company goals.
• Ensure cross-functional alignment and effective communication of regulatory CMC requirements and strategies.
• Provides expertise on CMC regulatory matters by interpreting global regulations and guidance and identifying opportunities and risks.
• Manages preparation, review, and submission of high-quality regulatory documents, that are accurate and compliant with global regulatory requirements to support development programs in close partnership with internal stakeholders and external partners.
• Leads regulatory CMC discussions with global regulatory authorities.
• Reviews and provides regulatory assessments on change controls.
• Works closely with subject matter experts within CMC operations, R&D and QA to strengthen internal capabilities.
• Builds/maintains relationships cross-functionally to ensure efficient implementation of regulatory activities.
• Contributes to improvements in department best practices and SOPs.
• Monitors and interprets evolving global regulatory CMC requirements and communicates potential impact to internal stakeholders.

Requirements

• Bachelor of Science in a scientific discipline with 10+ years relevant pharmaceutical experience or advanced degree (MS/PharmD/PhD) with 8+ years of relevant experience.
• At least 5 years prior experience in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics cell therapy, gene therapy or mRNA-based therapeutics.
• Deep experience in product development and understanding of US, international regulations, and ICH guidelines related to CMC development.
• Extensive experience in preparing quality sections of regulatory filings including health Authority briefing documents, IND/CTA/IMPDs, and BLA/MAAs following eCTD format.
• Demonstrated leadership, problem-solving ability, flexibility, and teamwork.
• Strong attention to detail and the ability to work individually, within a multidisciplinary team, or with external partners and vendors.

Nice-to-haves

• Device experience is desirable, but not required.