Senior Manager, Regulatory Affairs

Sarepta Therapeutics; City of Rochester (MA, NY); Hybrid; USD 132,000 - 165,000; Full time

Job summary

An innovative firm at the forefront of genetic medicine is seeking a dedicated Regulatory Affairs professional. This role involves leading CMC regulatory strategies and ensuring compliance with evolving regulations. You'll collaborate with cross-functional teams, manage submissions, and contribute to high-quality documentation for global health authorities. This hybrid position offers a unique opportunity to make a significant impact in the field of gene therapy while fostering a culture of authenticity and support. Join a passionate team committed to making a difference in patients' lives.

Benefits

Physical and Emotional Wellness Support

Financial Wellness Support

Caregiver Support

Qualifications

• 8+ years of experience in regulatory affairs with a focus on CMC.
• Strong understanding of ICH guidelines and regulatory processes.

Responsibilities

• Lead CMC regulatory strategies and submissions for assigned projects.
• Ensure compliance and support inspection readiness for regulatory documents.

Skills

Regulatory Affairs

Drug Development

Communication Skills

Project Management

Process Improvement

Education

Bachelor's Degree

Tools

Microsoft Office

Regulatory/Quality Systems

Job description

Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), with over 40 programs in various stages of development in gene therapy, RNA, and gene editing. In 2023, we launched our fourth therapy and the first-ever gene therapy to treat Duchenne.

We're looking for passionate individuals who see unlimited potential in themselves and are motivated by an unwavering commitment to patients.

What Sarepta Offers

At Sarepta, we deeply care about our community and believe in supporting them holistically. We aim to foster a culture that embraces authenticity and helps our team integrate work and personal life while maintaining productivity. Our benefits and resources support:

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

For a full list of benefits, visit: https://www.sarepta.com/join-us

The Importance of the Role

Lead or co-lead for one RA CMC development and/or marketed product, providing support for Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs. Collaborate with subject matter experts within CMC technical operations and QA within a CMC sub-team, serving as a member of the GRT. Contribute to the development of high-quality documentation (e.g., INDs, CTAs, NDAs, reports, correspondences) for global Health Authority interactions. May oversee junior regulatory personnel. Build and maintain global and cross-functional relationships to ensure effective communication and efficient regulatory activities for assigned programs. Apply and develop knowledge of regulatory procedures relevant to the assigned market.

The Opportunity to Make a Difference

• Develop CMC regulatory strategies for assigned projects, interpreting and applying regulatory and corporate guidelines.
• Coordinate preparation and submission of regulatory documents, manage change control assessments, maintain regulatory trackers, and oversee submission activities.
• Lead CMC submissions and respond to agency queries as needed.
• Ensure documentation compliance and support inspection readiness.
• Stay informed about evolving regulations and guidance.
• Contribute to establishing and implementing regulatory strategies within Global Regulatory Teams.
• Analyze situations and data considering organizational objectives and business trends.
• Manage budgets, schedules, and performance standards.
• Address issues impacting schedules and operations, understanding the potential for critical delays.

More about You

• Experience working in GRTs and cross-functional teams.
• Knowledge of drug development, ICH guidelines, and regulatory processes.
• Experience with IND/CTA, IMPDs, Orphan drug designation, Agency Advice, NDA, and MAA submissions.
• Understanding of submission content, format requirements, and successful project management.
• Strong communication skills, interpersonal, written, and verbal, with the ability to influence without authority.
• High ethical standards, attention to detail, and a sense of accountability.
• Ability to evaluate and suggest process improvements.
• RAC certification is recommended.
• Proficiency in Microsoft Office and regulatory/quality systems.
• Bachelor's degree or equivalent with 8+ years of relevant experience.

What Now?

We seek solution-oriented, critical thinkers who are comfortable with ambiguity, challenge themselves, and prioritize kindness and integrity. If this describes you, we encourage you to apply.

#LI-Hybrid #LI-CM1

This position is hybrid, requiring on-site work at one of Sarepta's U.S. facilities and occasional attendance at company events. The targeted salary range is $132,000 - $165,000 annually, commensurate with experience and other factors. Candidates must be authorized to work in the U.S. Sarepta offers competitive compensation and benefits. We are an Equal Opportunity/Affirmative Action employer and participate in e-Verify.