Manager – Global Regulatory Strategy

Why Sarepta? Why Now?

Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold a leadership position in Duchenne Muscular Dystrophy and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. Our next-generation siRNA platform is focused on chronically administered therapies for neurodegenerative and pulmonary diseases.  

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

Participates in clinical & nonclinical regulatory strategic discussions, supports multiple products’ clinical trial & registration activities. Responsible for cross-functional execution of regulatory activities at the team level to support assigned programs & markets. Supports the implementation of regulatory strategy for assigned markets & provides regulatory support for the registration/post-licensing activities of medicinal products. Maintains & 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

• 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

More about You

• 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 

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-HybridThis 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.