Senior Manager, CMC Regulatory

Third Rock Ventures - Cambridge, MA

- Mid Level

Cambridge, MA

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

About the position

As part of the Pharmaceutical Development team, this position will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs. Position requires weekly onsite presence.

Responsibilities

• Serve as CMC-regulatory lead for assigned projects.
• Develop and execute CMC global submission plans and timelines in accordance with project goals.
• Lead the preparation/plans, review, and on-time submission of CMC sections for IND/IMPD/CTA, NDA/MAA and other global regulatory filings including IB, DSUR, annual updates, briefing books etc. in conjunction with regulatory affairs and CMC/Pharmaceutical Development teams.
• Coordinate responses to CMC questions/RFIs from regulatory authorities in conjunction with CMC and regulatory affairs teams.
• Lead CMC-regulatory activities with cross-functional teams and act as the regulatory CMC liaison between CMC, regulatory affairs and/or program management.
• Manage regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations.
• Keep abreast of regulatory guidance and technical/scientific developments relevant to projects.

Requirements

• Strong background in Regulatory Affairs-CMC with a focus on small molecule clinical (IND/IMPD) and/or commercial (NDA/MAA) submissions.
• Proven ability to lead and manage regulatory CMC projects.
• In-depth knowledge of global CMC regulatory requirements and guidelines (e.g. FDA, EMA, ICH).
• Strong technical writing and document review skills.
• Excellent organizational skills, ability to multi-task and prioritize assignments.
• Operational creativity, strong problem-solving skills, self-motivated and able to work under pressure.
• Strategic thinking capabilities with a forward-looking perspective.
• Strong communication, planning, and collaboration skills.
• Attention to detail, follow-up/through skills; ability to work individually and within multi-disciplinary teams.
• Ability to effectively manage multiple projects with competing priorities.