New · posted Oct 15
Sarepta Therapeutics · Biotechnology
Associate Director, Regulatory Labeling and Disclosures
- Remote, US
- Remote
- Full-time
- Director
Open until filled
The role
The Importance of the Role
The Associate Director of Regulatory Labeling and Disclosures is a US remote based position. You will be responsible for leading global labeling activities for development and/or marketed products, and leading disclosure activities for applicable clinical trials. The Associate Director is responsible for the development, maintenance, and harmonization of core labeling (e.g., CCDS) and local labeling, ensuring compliance with applicable regulatory requirements while supporting business and lifecycle objectives. The Associate Director may also oversee the end-to-end operations for clinical trial registration, maintenance and results posting on Health Authority-managed databases worldwide (e.g., Clinicaltrials.gov, EudraCT). The Associate Director is responsible for effectively partnering and engaging with internal (e.g., cross-functional study teams, senior management) and external key stakeholders (e.g., vendors, business partners) to ensure business needs and regulatory requirements are met, prioritized, and communicated.
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
More about You
- BS in related field with 10+ years of related experience. Strong scientific education preferred.
- Experience in Regulatory Labeling (e.g., developing core and local labeling, label negotiations with Health Authorities) and/or Disclosures (e.g., publishing applicable clinical trial registrations and/or results), preferred
- Proficiency with Microsoft Office Applications; Word, Excel, Outlook, and regulatory systems.
What you need
What you'll do
Primary Responsibilities Include
- Leads cross-functional labeling teams to develop and maintain US Full Prescribing Information and associated local labeling documents, Company Core Data Sheets (CCDS), and Target Product Labeling (TPL) for marketed and development products
- Contributes to the formulation of global labeling strategy and assists international regulatory colleagues in development of local or regional labeling consistent with reference labeling
- Responsive to business goals offering creative and compliant solutions while ensuring company regulatory integrity and consistency in communications and activities
- Ensures alignment between reference labeling and regional adaptations while supporting affiliate needs
- Collaborates with cross-functional leads on package labeling (artwork) development, updates, and maintenance
- Supports Global Regulatory Strategists with HA interaction labeling strategy, including submissions, responses to questions, and negotiations.
- May lead or support coordinating activities for clinical trial registration, including redactions of clinical trial documents, registration maintenance and results posting to clinicaltrials.gov, EU CTIS, and similar databases worldwide in compliance with procedures, and applicable regulations
- Manage process for individual participant data (IPD) report generation at the end of clinical studies and act as point on external IPD requests received through Sarepta's privacy team
- Building and maintaining relationships with the Global Regulatory Affairs team, cross functional contributors, and the external vendors to support effective, efficient communication and maintain clinical trial disclosure and transparency compliance, accuracy, and completeness
- Involved in developing, modifying, and executing company policies that affect immediate operations and may also have company-wide effect
- Ensures documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs
- Maintains knowledge of relevant evolving regulation and guidance
- Key contributor within Global Regulatory Teams to establish and implement regulatory strategy
- Interacts across levels and line functions to lead team through successful engagements with Health Authorities
Pay and benefits
$161,000 – $201,000 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
Financial wellness
Support for caregivers
Competitive compensation and benefit package
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 $160,800 - $201,000 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 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 12% below the US median for Labeling & Promotion roles at this level.
This roleEmployer provided
Director roles in the US35 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $161,000 | — | $201,000 |
| All US (middle half) | $197,500 | $205,500 | $216,750 |
This role: Sarepta Therapeutics's own published range. Comparisons: the base pay employers published on open Labeling & Promotion roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Labeling & Promotion
The general path across 74 open Labeling & Promotion 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 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions9
- Collaboration and leadership9
- GMP and compliance4
- Documentation and SOPs4
- Data and digital systems1
Company hiring pulse
Sarepta Therapeutics on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 3
- Locations
By discipline
- Quality3 75%
- Regulatory1 25%
By level
- Director2 50%
- Manager2 50%
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Associate Director, Regulatory Labeling and Disclosures at Sarepta Therapeutics
Open until filled. $161K–$201K a year, employer provided.