Director, Regulatory Strategy

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), and we currently have more than 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 people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
 

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
 

The Importance of the Role

Works as Global Regulatory Leads (GRLs). Positively contributes to the global regulatory strategy for clinical and commercial therapeutic programs. Facilitate identification and resolution of scientific and regulatory issues with the regulatory agencies. Directs the preparation and submission of INDs, NDAs, BLAs.
Potential of management of junior regulatory personnel. Manages contractual and budgetary responsibilities with best business practices.
Remains current with evolving regulation and guidance for integrated review of guidance to develop strategies.

The Opportunity to Make a Difference

• Responsible for or contributes to proactively formulating regulatory strategies that provide a streamlined development and approval timeline while accurately interpreting and reflecting regulatory and Corporate guidelines
• Plans and manages integration of multi-disciplinary regulatory programs into the project team development plans for all assigned projects
• Represents Sarepta at FDA and EMA agencies for all assigned products. Oversees the planning and conduct of meetings with regulatory agencies as appropriate 
• Initiates and responds to regulatory agency contacts (telephone, written, meetings, etc.) to assure expedient and efficient review and approval of products
• Provides Sarepta with current and proposed regulatory, scientific, and pertinent legal issues (i.e., external meetings, workshops, and conferences)
• Ensures that all documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance, and are presented in a way that facilitates agency review.
• Guides project teams to implement appropriate regulatory strategies
• Supervises and coordinates all regulatory activities required for submissions to regulatory agencies for assigned products
• Leads Global Regulatory Team(s)
• Contributes to, with the ability to own, SOPs and internal regulatory quality procedures

More about You

• Limited supervision as an experienced professional with an excellent understanding of assigned markets with the ability to execute responsibilities independently
• Directs and controls the activities of a broad functional area through several department managers within the company 
• Assists executives and/or senior directors in defining organizational goals and strategic plans
• Makes final decisions on administrative or operational matters and ensures effective achievement of objectives 
• Has overall control of planning, staffing, budgeting, managing expense priorities, and recommending and implementing changes to methods
• Expectation to develop and mentor junior personnel
• Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company
• Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures budgets and schedules meet corporate requirements.
• Works on objectives that have critical impact on functional area and the organization
• Erroneous decisions or failure to achieve results will add to costs, result in critical delay(s) and may have serious impact on the overall success of functional, division, or company operations
• Detailed knowledge of clinical and nonclinical data requirements for product labeling
• Demonstrated knowledge of drug development process
• Knowledge of laws and regulations affecting the pharmaceutical industry, and regulatory experience
• Experience with preparing regulatory submissions and briefing packages for regulatory meetings 
• Personal leadership, with an ability to bring divergent views together, agree on common objectives and engender enthusiasm even in challenging circumstances
• Excellent interpersonal, collaboration, written, verbal and visual communication skills with ability to influence cross-functionally at all levels within the organization
• Solid sense of accountability, sound judgement and decision-making skills, and strong attention to detail
• BS or equivalent with 12+ years of related experience
• Prior regulatory affairs experience in major markets is expected

What 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.
 

#LI-Remote

#LI-CM1

This position is remote. However, 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 $180,000 - $225,000 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. Apply