New · posted Oct 26
Sarepta Therapeutics · Biotechnology
Manager, Global Regulatory Strategy
- Cambridge, MA
- Hybrid
- Full-time
- Manager
The role
The Importance of the Role
Participates in clinical and nonclinical regulatory strategic discussions, supports multiple products’ clinical trial and registration and activities. Responsible for cross-functional execution of regulatory activities at the team level to support assigned programs and markets. Supports the implementation of regulatory strategy for assigned markets & provides regulatory support for the registration/post-licensing activities of medicinal products. Maintains and develops knowledge of assigned market regulatory procedures. Builds/maintains relationships within GRA & other stakeholders to support effective communication & efficient implementation of regulatory activities for assigned markets & activities.
The Opportunity to Make a Difference
- Acts as the regulatory affairs clinical lead for clinical trial activities, including but not limited to planning, preparation and tracking of CTAs, response to agency queries, IP release, CTA Questionnaires, label review, etc.
- Reviews of all regulatory agency submission materials for submissions conducted by a CRO on behalf of Sarepta
- Implements regulatory activities in support of product lifecycle activities for assigned markets
- Ensures effective assembly & preparation of country specific submissions
- Provides regulatory support to Global Regulatory Lead in definition & communication of regulatory strategy for assigned markets for assigned products & inputs into project teams via GRT, in support of GRA goals
- Contributes to global regulatory strategy and execution and participates in Global Regulatory Teams
- Works closely with RA CRO to maintain trial progression and compliance
- Provides regulatory guidance, in relation to clinical trial activity, and updates cross- functionally as needed
- Ensures documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs
- Develops and maintains knowledge of relevant evolving regulation and guidance
- Works on issues where analysis of situations or data requires evaluation of a variety of factors and an understanding of current business trends
- Escalates and effectively communicates issues to supervisor and other relevant RA stakeholders
- Follows processes and operational policies in selecting methods and techniques for obtaining solutions
- Works on objectives that have meaningful impact on unit and the organization
- Erroneous decisions or failure to execute has medium impact to overall GRA deliverables
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
What you need
- BS or equivalent with 5-8 years of relevant experience
Skills and Competencies
- Knowledge of drug development and regulatory process
- Knowledge of ICH guidelines, IND/ CTA, IMPDs, Orphan drug designation
- Demonstrated experience preparing submissions, with and a clear understanding of submission content and format requirements
- Adaptive communication skills (including interpersonal, written, verbal)
- Ability to successfully multi-task, prioritize, manage projects/timelines, and organize/track complex information
- Experience working in cross functional project teams
- Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and details
- Proficiency with Microsoft Office Applications; Word, Excel, Outlook, and Adobe Suite systems
Pay and benefits
$116,000 – $145,000 a year
Employer providedWhat Now?
We’re always looking for solution-oriented, critical thinkers.
So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
Physical and emotional wellness support
Financial wellness support
Support for caregivers
Competitive compensation and benefit package
Where you'll work
Cambridge, MAHybridOpen in Maps (opens in a new tab)
More jobs in Cambridge, MA
From the posting
About Sarepta Therapeutics
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
Equal opportunity, accessibility and legal noticesSarepta Therapeutics's statements, word for word
position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.The targeted salary range for this position is $116,000 - $145,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.Candidates must be authorized to work in the U.S.Sarepta Therapeutics offers a competitive compensation and benefit package.Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
Job intelligence
The context around this role
Live data · October 26, 2026
Salary intelligence
How the pay compares
This role's midpoint is 20% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Manager roles in Massachusetts7 roles publishing pay
Manager roles in the US55 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $116,000 | — | $145,000 |
| Massachusetts (middle half) | $136,500 | $138,000 | $155,250 |
| All US (middle half) | $146,750 | $162,500 | $174,250 |
This role: Sarepta Therapeutics's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 26, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 310 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Sarepta Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions8
- Collaboration and leadership7
- GMP and compliance2
- Documentation and SOPs2
- Lab testing and methods1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Sarepta Therapeutics on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 4
- Locations
By discipline
- Quality3 60%
- Regulatory2 40%
By level
- Manager3 60%
- Director2 40%
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Manager, Global Regulatory Strategy at Sarepta Therapeutics
Open until filled. $116K–$145K a year, employer provided.