Senior Manager, CMC Regulatory

Sarepta Therapeutics • Cambridge, MA

12h • Hybrid

About The Position

Lead or co-lead regulatory affairs for one CMC development or marketed product, providing Chemistry, Manufacturing and Controls (CMC) regulatory support. The role works closely with subject matter experts in CMC technical operations and Quality Assurance within a CMC sub-team structure and serves as a member of the Global Regulatory Team (GRT). It contributes to high-quality, fit-for-purpose regulatory documentation, including INDs, CTAs, NDAs, reports, and correspondence, to support interactions with global health authorities. The role may oversee junior regulatory personnel and builds relationships across global and cross-functional teams to support effective communication and implementation of regulatory activities. It applies and develops knowledge of relevant market regulatory procedures.

The position contributes to CMC regulatory strategies for assigned projects and programs, interpreting applicable regulatory and corporate guidelines. It coordinates preparation and submission of documents to regulatory agencies, completes change-control regulatory assessments, maintains regulatory trackers, and supports submission preparation. It may lead CMC submissions and agency responses. The role ensures documentation management and recordkeeping meet regulatory expectations and Sarepta SOPs, supports inspection readiness, and maintains knowledge of evolving regulations and guidance. As a GRT contributor, it helps establish and implement regulatory strategy.

The role addresses issues requiring knowledge of organizational objectives and business trends; establishes and ensures adherence to budgets, schedules, work plans, and performance requirements; and works on objectives with significant impact on the function and organization. Erroneous decisions may critically delay schedules or unit operations and jeopardize business activities. The position is hybrid, requiring on-site work at a Sarepta facility in the United States and/or attendance at company-sponsored in-person events from time to time. Candidates must be authorized to work in the United States.

Requirements

• Bachelor’s degree or equivalent.
• At least 8 years of relevant experience.
• Experience working in Global Regulatory Teams and cross-functional teams.
• Knowledge of drug development, ICH guidelines, and regulatory processes.
• Experience with IND/CTA, IMPDs, orphan drug designation, agency advice, and NDA and/or MAA submissions.
• Demonstrated experience with and clear understanding of submission content and format requirements.
• Ability to manage projects and timelines, organize and track complex information, prioritize, and communicate with internal and external stakeholders.
• Adaptive interpersonal, written, and verbal communication skills, including the ability to influence others without authority.
• Accountability, sound judgment, high ethical standards, and attention to quality and detail.
• Ability to evaluate and recommend process improvements and suggest or implement best practices.
• Proficiency with Microsoft Office applications, including Word, Excel, and Outlook, Adobe, and regulatory/quality systems.
• Must be authorized to work in the United States.

Nice To Haves

• RAC certification is recommended.

Responsibilities

• Lead or co-lead regulatory affairs for an assigned CMC development or marketed product.
• Provide CMC Regulatory Affairs support and collaborate with CMC technical operations and Quality Assurance subject matter experts within a CMC sub-team.
• Contribute to high-quality, fit-for-purpose regulatory documents, including INDs, CTAs, NDAs, reports, and correspondence, for global health authority interactions.
• Develop CMC regulatory strategies for assigned projects and programs, accurately interpreting regulatory and corporate guidelines.
• Coordinate preparation and submission of documents to regulatory agencies in support of regulatory strategy and corporate goals.
• Complete change-control regulatory assessments, maintain regulatory trackers, and conduct submission-preparation activities.
• Lead CMC submissions and agency responses when needed.
• Ensure documentation management and recordkeeping comply with regulatory expectations and Sarepta SOPs.
• Support inspection-readiness preparation.
• Maintain and further develop knowledge of relevant evolving regulations and guidance.
• Contribute to establishing and implementing regulatory strategy as a member of Global Regulatory Teams.
• Build and maintain global and cross-functional relationships to promote effective communication and efficient implementation of regulatory activities.
• Establish and ensure adherence to budgets, schedules, work plans, and performance requirements.
• May oversee activities of junior regulatory personnel.

Benefits

• Comprehensive benefits and work-life resources supporting physical and emotional wellness, financial wellness, and caregivers.
• Competitive compensation and benefit package.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior