Senior Manager, Global Regulatory Affairs, CMC

Senior Manager, Global Regulatory Affairs, CMC

Industry: Biopharmaceutical / Life Sciences

Location: United States

Work Arrangement: Remote

Employment Type: Full-time

A global biopharmaceutical organization is seeking a Senior Manager, Global Regulatory Affairs, CMC to support registration and CMC regulatory activities for commercial and development programs involving biological products across international markets.

This role will contribute to global regulatory strategy, submission development, regulatory agency interactions, and ongoing product lifecycle management while partnering closely with cross-functional teams.

Key Responsibilities

• Manage the preparation and review of CMC sections within Module 2 and Module 3 of regulatory submissions, including INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests and briefing documents.
• Support the development and execution of global Regulatory CMC strategies for commercial products and early- and late-stage development programs.
• Conduct risk assessments and communicate potential regulatory risks and strategic considerations to cross-functional and regulatory teams.
• Coordinate preparation and timely submission of responses to regulatory agencies while managing associated timelines.
• Represent Regulatory CMC in meetings with internal stakeholders, business partners and, where appropriate, regulatory agencies.
• Support ongoing regulatory compliance through change control, regulatory impact assessments and regulatory information management processes.
• Maintain current regulatory product information supporting clinical and commercial product release activities.
• Verify electronic publishing of regulatory submissions.
• Identify and support continuous improvement opportunities across Regulatory Affairs and CMC processes.
• Ensure activities comply with applicable company policies, procedures, regulatory requirements and training expectations.

Required Knowledge & Experience

• Strong understanding and strategic application of regulations and guidelines across the drug development and lifecycle management process, preferably for biological products.
• Solid knowledge of CMC regulatory principles with the ability to develop clear, well-supported regulatory positions.
• Experience preparing and managing electronic Common Technical Document (eCTD) CMC regulatory submissions, including MAAs, BLAs, variations, responses, CTAs and INDs.
• Working knowledge of FDA, EMA and ICH guidelines.
• Strong interpersonal and communication skills with the ability to work independently and collaboratively within multidisciplinary teams and with external partners and regulators.
• Experience working within global, cross-functional regulatory environments.

Education

• Bachelor's degree in a relevant discipline such as life sciences, healthcare, or a related field, or equivalent relevant experience.
• Professional experience in Regulatory Affairs, CMC, or a related discipline.

Compensation

For US-based candidates, the anticipated base salary range is $140,000–$210,000, depending on qualifications, experience, skills, knowledge and other relevant factors.

Additional compensation may include an annual bonus or incentive compensation, equity opportunities and a comprehensive benefits package.

Work Arrangement

Remote — United States

This opportunity is suited to an experienced Regulatory Affairs professional with strong CMC expertise and experience supporting global regulatory submissions for biological products.