Senior Manager, Regulatory Affairs Device

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

Job summary

Join an innovative company at the forefront of genetic medicine, where your expertise in regulatory affairs will drive impactful projects. In this role, you will lead product registration activities and collaborate with cross-functional teams to ensure compliance with evolving regulations. Your contributions will directly influence the development of groundbreaking therapies for muscular dystrophies. This position offers a unique opportunity to make a difference in patients' lives while working in a supportive and dynamic environment that values integrity and kindness.

Benefits

Competitive Compensation

Comprehensive Benefits

Support for Caregivers

Wellness Programs

Qualifications

• 8+ years of relevant experience in regulatory affairs.
• Strong knowledge of drug development and regulatory frameworks.

Responsibilities

• Prepare regulatory submissions and correspondence with authorities.
• Manage regulatory activities for submissions to agencies.

Skills

Regulatory Strategies

Project Management

Communication Skills

Attention to Detail

Problem Solving

Education

Bachelor's Degree

Tools

Microsoft Office

Regulatory 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 development across gene therapy, RNA, and gene editing. In 2023, we launched our fourth therapy and the first gene therapy for Duchenne.

We're seeking individuals who see unlimited potential in themselves and are driven by a steadfast commitment to patients.

What Sarepta Offers

At Sarepta, we deeply care about our community and support them holistically. We foster a culture where people bring their whole selves to work, striving to balance 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

Contribute to regulatory strategies for investigational devices, Companion Diagnostics (CDx), and Combination Products to support business objectives. Lead product registration activities and oversee clinical trial regulatory affairs for multiple programs. Develop high-quality documentation (e.g., IDEs, IVDR technical documents, reports, correspondences) for global Health Authority interactions. May oversee junior regulatory personnel. Build and maintain relationships globally and cross-functionally to ensure effective communication and implementation of regulatory activities. Apply and develop knowledge of regulatory procedures in assigned markets.

The Opportunity to Make a Difference

• Prepare regulatory submissions and correspondence with authorities (e.g., IDE, SRD, Q-subs, EU Technical Files)
• Manage regulatory activities for submissions to agencies
• Collaborate with diagnostic partners on regulatory needs and pathways
• Engage stakeholders to improve processes
• Develop regulatory strategies reflecting guidelines
• Ensure documentation compliance and support inspection readiness
• Stay updated on evolving regulations
• Participate in Global Regulatory Teams (GRTs)

Impact and Scope

• Work on issues requiring analysis aligned with organizational goals
• Manage budgets, schedules, and performance standards
• Impact functional and organizational objectives
• Erroneous decisions could cause delays or jeopardize activities

More about You

• Bachelor’s degree or equivalent with 8+ years relevant experience
• Experience with GRTs and cross-functional teams
• Knowledge of drug development, ICH guidelines, and regulatory frameworks for devices or drug/device combos
• Experience with clinical studies for devices, drugs, or combos
• Understanding of submission content and formats
• Project management and organizational skills
• Strong communication and influencing skills
• High ethical standards, accountability, and attention to detail
• Ability to suggest process improvements
• Proficiency with Microsoft Office and regulatory systems

What Now?

We seek solution-oriented, critical thinkers comfortable with ambiguity and candor. If you relish challenges and prioritize kindness and integrity, we encourage you to apply.

#LI-Remote #LI-CM1

This position is remote but may require on-site work at Sarepta facilities in the U.S. and attendance at company events. The 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 participating in e-Verify.