Senior Manager, CMC Regulatory - Meet

Job Summary:

The Senior Manager, CMC Regulatory will play a critical role in the Regulatory CMC (Chemistry, Manufacturing, and Controls) department, leading the planning, preparation, and submission of global regulatory CMC-related content for clinical trial applications, marketing applications, and periodic reports. This individual will ensure that all submissions meet the relevant requirements for US and Ex-US markets, in alignment with the regulatory strategy. The Senior Manager will also provide strategic guidance on manufacturing changes, collaborate with cross-functional teams, and manage interactions with regulatory authorities to support the overall submission process.

Key Responsibilities:

• Lead the planning, preparation, and submission of global regulatory CMC-related content for clinical trial applications, marketing applications, and periodic reports in the US and Ex-US markets.
• Ensure all sections of submissions are complete, accurate, well-written, and compliant with relevant regulatory requirements.
• Collaborate closely with the Regulatory CMC Product Lead to assess proposed manufacturing changes and provide strategic regulatory guidance for optimal implementation of changes.
• Develop and review regulatory documents to ensure accuracy and compliance with current CMC regulations.
• Manage timelines and deliverables to ensure that regulatory submissions are aligned with program milestones.
• Proactively identify potential issues and escalate when necessary to maintain submission timelines.
• Build and maintain strong relationships with Regulatory Affairs, Manufacturing, Technical Development, Sites, and Quality teams to support the preparation of regulatory submissions.
• Provide regulatory advice and guidance to technical subject matter experts based on a deep understanding of current CMC regulatory requirements.
• Manage interactions with global regulatory authorities (FDA, EMA, Health Canada, etc.) for assigned projects, including addressing health authority queries and providing timely responses.
• Ensure that all regulatory communications are handled in accordance with regulatory guidelines and timelines.
• Process documentation requests to support key regulatory application activities, ensuring that all necessary documentation is available and accurate.

Qualifications:

• BA/BS degree in Life Sciences, Chemistry, Molecular Biology, or a similar field is desirable. An advanced degree (MS, PhD) is a plus.
• A proven track record in Regulatory Affairs, with experience in Chemistry, Manufacturing, and Controls (CMC) regulatory submissions, ideally within the pharmaceutical or biotechnology industry.
• Strong knowledge of global CMC regulatory requirements and submission processes (US, EU, and other international markets).
• Experience managing complex regulatory submissions and interactions with regulatory authorities.