Sr. Manager/Associate Director, Regulatory Strategy at Sarepta Therapeutics
Posted in Other 7 days ago.
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Type: Full Time
Location: Cambridge, Massachusetts
Sarepta Therapeutics is a commercial-stage biopharmaceutical company focused on the discovery and development of precision genetic medicines to treat rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying Duchenne muscular dystrophy (DMD) drug candidates. For more information, please visit www.sarepta.com.
Foster drug development by facilitating identification and resolution of scientific and regulatory issues with the regulatory agencies. Direct the implementation of regulatory strategy for assigned products. Collaborate with other colleagues in Regulatory Affairs at Sarepta on preparation of internal teams for FDA and EMA meetings and interactions. Interact successfully with all levels of management. Direct the preparation and submission of INDs, CTAs, NDAs, reports and correspondences to the appropriate regulatory agencies for assigned projects.
Primary responsibilities include:
* Contribute to proactively formulating regulatory strategies that provide a streamlined development and approval time line while accurately interpreting and reflecting regulatory and Corporate guidelines.
* Assist with planning, preparation for and conduct of meetings with Regulatory agencies for all assigned products. Initiate and respond to regulatory agency contacts (telephone, written, meetings, etc.) to assure expedient and efficient review and approval of products.
* Ensure 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.
* Guide project teams to implement appropriate regulatory strategies.
* Supervise and coordinate all regulatory activities required for submissions to regulatory agencies for assigned products.
Education and Skills Requirements:
* Demonstrated knowledge of drug development process is essential. Knowledge of laws and regulations affecting the pharmaceutical industry, and regulatory experience.
* Experience with preparing IND submissions and briefing packages for regulatory meetings essential.
* Experience with successful NDA, sNDA and/or BLA filing preferred.
* Prior experience working with EMA preferred.
* Advanced scientific degree preferred. B.A./B.S. or higher degree (s) in the sciences, or health related field minimum, with 5 years regulatory experience. Demonstrates personal leadership, with a natural ability to bring divergent views together, agree common objectives and engenders enthusiasm even in challenging circumstances.
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.
Cambridge, Massachusetts, United States