Senior Cmc Regulatory Strategy Manager

Position Summary

You will lead Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle activities. You will work with cross‑functional teams across development, manufacturing, quality and regulatory to prepare submissions and respond to regulatory requests. Your work will directly support timely access to medicines and continued supply for patients. We value clear communicators, pragmatic problem solvers, and collaborative colleagues who enjoy influencing technical and regulatory decisions.

• Drive the CMC strategy, coordinate the timely preparation and authorship of technical (CMC) regulatory documents to support lifecycle maintenance submission content, in accordance with applicable regulatory and scientific standards, and taking into account evolving regulatory requirements. Identify risks to the business associated with submission data and information packages and provide and communicate well‑defined risk mitigation strategies.

• Mentor or train staff; may have direct line management responsibility. Manage project activities for multiple complex projects and teams simultaneously, including reporting staff as appropriate. Provide strategic direction, data assessment and conclusions within and across departments. Establish organizational networks (internal and external) and understand departmental constraints/pressure within a highly complex organization.

• Engage and may lead CMC Subject Matter Expert activities, both internally (for increased compliance, harmonization and efficiency) and externally (external advocacy and shaping the regulatory environment).

• Deliver CMC regulatory strategy to support major inspections (e.g., PAIs) or quality incidents (PIRCs).

• Hold accountability for submission content. Understand, interpret and advise on regulations, guidelines, procedures and policies relating to development, registration and manufacturing of biopharmaceutical products to expedite submission, review and approval of global CMC applications.

• Ensure all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply. Ensure information submitted in lifecycle maintenance submissions meets regional requirements, allowing maximum supply/production/quality flexibility with minimal unanticipated questions.

• Formulate novel approaches and influence people, evaluating and improving CMC regulatory processes, policies and systems to enhance the efficiency and quality of departmental work.

• Directly communicate complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence project and policy issues that are aligned with business needs, ensuring optimum position for the company.

• Operate with considerable independence, except for matters that affect corporate or agency policies. Rapidly and appropriately communicate sensitive matters or those with potential for high business impact.

• Participate in corporate evaluation and provide CMC regulatory support/advice to in‑licensing and divestment projects.

• Bachelor’s degree in life sciences, pharmacy, chemistry, engineering or related field.
• 6+ years of CMC regulatory experience in pharmaceutical, biologic, device or combination product development.
• Experience preparing and contributing to regulatory submissions (CTD modules, amendments, INDs, BLAs/NDAs or equivalents).
• Experience with GMP and manufacturing processes and how they relate to regulatory submissions.
• Experience with complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
• Experience handling complex global CMC issues through continuous change and improvement.
• Experience in major post‑approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management).

• Advanced degree (Master’s or PhD) in a relevant scientific discipline.
• Direct experience leading interactions with U.S. FDA or other global regulatory agencies.
• Experience managing multiple complex projects or supervising small teams.
• Experien…