Summary

Lead or co-lead for one RA CMC development and/or marketed product and provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. Works closely with subject matter experts within CMC technical operations and QA working within a CMC sub-team structure and serving as a member of the GRT. Contributes to the development of fit for purpose high quality documentation (e.g., INDs, CTAs, NDAs, reports, and correspondences) to support global Health Authority interactions. May oversee activities of junior regulatory personnel. Builds/maintains relationships globally and cross-functionally to ensure effective communication & efficient implementation of regulatory activities for assigned programs. Applies and further develops knowledge of assigned market regulatory procedures.

Job description

The Importance of the Role

Lead or co-lead for one RA CMC development and/or marketed product and provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. Works closely with subject matter experts within CMC technical operations and QA working within a CMC sub-team structure and serving as a member of the GRT. Contributes to the development of fit for purpose high quality documentation (e.g., INDs, CTAs, NDAs, reports, and correspondences) to support global Health Authority interactions. May oversee activities of junior regulatory personnel. Builds/maintains relationships globally and cross-functionally to ensure effective communication & efficient implementation of regulatory activities for assigned programs. Applies and further develops knowledge of assigned market regulatory procedures.

The Opportunity to Make a Difference

Contributes to developing CMC regulatory strategies for assigned projects and programs while accurately interpreting and reflecting regulatory guidelines and corporate guidelines
Coordinates the preparation and submission of documents to appropriate regulatory agencies for assigned projects and programs to implement regulatory strategy in line with corporate goals Responsible for completing change control regulatory assessments, maintenance of regulatory tracker and submission preparation activities.
May lead CMC submissions and agency responses.
Ensure documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs.
Required to support preparation for inspection readiness
Maintains/further develops knowledge of relevant evolving regulation and guidance
Global Regulatory Teams –contributor to establish and implement regulatory strategy

Impact and Scope

Works on issues where analysis of situations or data requires a knowledge of organizational objectives and current business trends
Establishes and assures adherence to budgets, schedules, work plans, and performance requirements
Works on objectives that have major impact on functional area and the organization
Erroneous decisions may result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.

More about You

Experience working in GRTs and cross functional teams
Knowledge of drug development, ICH guidelines and regulatory process.
Experience of IND/CTA, IMPDs, Orphan drug designation, Agency Advice, NDA and/or MAA submission
Demonstrated experience with and a clear understanding of submission content and format requirements
Ability to successfully manage projects/timelines, organize/track complex information & prioritize, by communicating with internal and external stakeholders
Adaptive communication skills (including interpersonal, written, verbal) and able to influence others without authority
Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and details
Ability to evaluate and recommend process improvement and suggest/implement best practices.
RAC certification recommended
Proficiency with Microsoft Office Applications; Word, Excel, Outlook, Adobe, and regulatory/quality systems.
BS or equivalent, 8+ years relevant experience

Requirements

Experience working in GRTs and cross functional teams
Knowledge of drug development, ICH guidelines and regulatory process
Experience of IND/CTA, IMPDs, Orphan drug designation, Agency Advice, NDA and/or MAA submission
Demonstrated experience with and a clear understanding of submission content and format requirements
Ability to successfully manage projects/timelines, organize/track complex information & prioritize, by communicating with internal and external stakeholders
Adaptive communication skills (including interpersonal, written, verbal) and able to influence others without authority
Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and details
Ability to evaluate and recommend process improvement and suggest/implement best practices
RAC certification recommended
Proficiency with Microsoft Office Applications; Word, Excel, Outlook, Adobe, and regulatory/quality systems
BS or equivalent, 8+ years relevant experience
Candidates must be authorized to work in the U.S.

Benefits

Physical and Emotional Wellness
Financial Wellness
Support for Caregivers

Company overview

Sarepta Therapeutics is a global biotechnology company headquartered in Cambridge, Massachusetts, focused on developing precision genetic medicines for rare diseases. Founded in 1980, the company has evolved into a commercial-stage biopharmaceutical leader with a specialized focus on RNA-based therapeutics and gene therapies. Sarepta's primary mission centers on treating devastating rare genetic disorders, particularly Duchenne muscular dystrophy (DMD), a progressive muscle-wasting disease affecting children. The company has developed multiple FDA-approved treatments including Exondys 51, Amondys 45, Vyondys 53, and the groundbreaking gene therapy ELEVIDYS. Sarepta employs approximately 1,300-1,400 professionals and maintains research facilities across multiple locations. The company's scientific platform leverages Morpholino oligomer technology for exon-skipping therapies and advanced adeno-associated virus (AAV) vectors for gene therapy delivery. With a market capitalization exceeding $2 billion, Sarepta continues to expand its pipeline to address additional rare diseases while building the world's largest gene therapy manufacturing capacity to accelerate patient access to transformative treatments.