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Sr. Director, Regulatory Policy Engagement

Employer
Sarepta Therapeutics
Location
Washington, DC
Closing date
Aug 19, 2019

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Industry
Other
Function
Executive, Management, Director
Hours
Full Time
Career Level
Experienced (Non-Manager)
The Position: In this newly created role, the Senior Director, Regulatory Policy and Engagement will lead the development and implementation of Sarepta's positions on regulatory policies that impact development of treatments for rare diseases, including gene therapies. The successful candidate will work cross-functionally to develop strategic plans to advance regulatory policy issues and engage regulatory authorities. The role will report to the company's Vice President, Global Policy, Government, and Patient Affairs. Primary Responsibilities Include: - Advance Sarepta's position on key regulatory policy issues by engaging regulatory authorities, trade and patient associations and internal subject matter experts. - Assist and advise leadership on regulatory policy issues related to the company's portfolio and pipeline, including establishing priorities, and proactively developing and executing regulatory policy advocacy plans. - Develop strategic responses to regulatory and policy issues that may impact the company, including: gene therapy, gene editing, rare diseases, clinical trial design, real-world evidence and patient-focused drug development. - Provide policy support to Regulatory Affairs, ensuring internal awareness of policy landscape and providing regulatory advice to support strategy development. - Engage with regulatory authorities and fulfill commitments on policy issues, including Sarepta-FDA policy meetings, workshops and patient-focused meetings. - Prepare and deliver regulatory intelligence summaries, including impact analysis. - Analyze draft guidance and develop comments. - Represent Sarepta at external events including panels, briefings, conferences, etc. Education and Skills Requirements: - 10+ years of experience in the healthcare, pharmaceutical industry, trade associations, or the Food and Drug Administration. - Experience with rare disease preferred and gene therapy a plus. - Proven teamwork and collaboration skills, with a demonstrated ability to work collaboratively with colleagues, industry trade associations, and influential policy organizations. - A high level of energy and passion toward patients, science and public health. - Self-initiating, well-organized and capable of managing multiple projects simultaneously and independently. - Demonstrated ability to develop innovative solutions. - Bachelor's Degree required, advanced degree preferred. Candidates must be authorized to work in the US Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

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