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Positively contributes to the regulatory probability of success for clinical and commercial therapeutic programs. Provides regulatory leadership for early research development products, conducts external regulatory due diligence activities and works on assigned products to ensure compliance with applicable global regulatory requirements. Facilitates identification and resolution of scientific and regulatory issues with the regulatory agencies. Directs the preparation and submission of INDs, NDAs, BLAs. Management of regulatory personnel with oversight and responsibility across the organization. May manage contractual and budgetary responsibilities with best business practices. Champions to stakeholders at all levels within the organization the development of company goals regarding compliant commercial activities and is responsible for integrating company goals into regulatory strategy. Participate in cross-functional leadership and appropriate non-therapeutic activities to increase capabilities across Sarepta. Enables a culture of compliance supporting a strong regulatory infrastructure and SOPs as required that supports inspection readiness. Sponsor/Lead for cross functional workstreams.

Primary Responsibilities Include

• May lead the Regulatory Strategy function
• Work directly with the Research Organization to develop regulatory strategies
• Work on assigned external due diligence activities
• Leads multiple product platform teams with responsibilities to deliver all the regulatory CMC objectives
• May serve as the Global Regulatory Lead for one or more development and/or marketed product
• Remains current with evolving regulation and guidance
• Responsible for, with proactive contribution to formulating regulatory strategies that provide a streamlined development and approval timeline while accurately interpreting and reflecting regulatory and corporate guidelines
• Directs and guides project teams to implement appropriate regulatory strategies.
• Directs, plans, and manages integration of multidisciplinary regulatory programs into the project team development plans for all assigned projects
• Represents Sarepta at FDA (and other regulatory agencies) for all assigned products; oversees the planning and conduct of meetings with regulatory agencies as appropriate
• Supervises and coordinates all regulatory activities required for submissions to regulatory agencies for assigned products; initiate and respond to regulatory agency contacts (telephone, written, meetings, etc.) to assure expedient and efficient review and approval of products
• Maintains Regulatory SOPs in compliance with global regulations. Supports GRA Leadership, leading the development of new departmental SOPs and identifies and drives strategic initiatives such as process improvements and/or departmental projects
• 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
• Leads across Sarepta with solutions for current and proposed regulatory, scientific, and pertinent legal issues (i.e., external meetings, workshops, and conferences)
• Collaborates and influences externally to enable regulatory success
• Key contributor GRA department & RA leadership team
• Works on objectives that have critical impact
• Erroneous decisions will result in critical delay(s) in schedules/ unit operations & may jeopardize overall business activities
• Ensures alignment with organizational business objectives both with in GRA, cross-functionally and externally (Agencies, industry groups)

Desired Education And Skills

• BS or equivalent with 15+ years of related experience with demonstrated knowledge of drug development process is essential, as well as knowledge of laws and regulations affecting the pharmaceutical industry and regulatory experience.
• Experience of successful NDA and/or BLA filing is essential
• Demonstrated leader with a natural 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
• Strong analytical skills and strategic thinking
• Proven ability to successfully manage projects and timelines, organize/track complex information, prioritize accordingly, and the ability to quickly adjust to shifting priorities and demanding timelines when necessary
• Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and attention to detail
• Experience working with stakeholders/partners at all levels, globally, across the organization
• Demonstrated ability to understand and process business goals and interpret business risk
• High degree of professional ethics, integrity, and responsibility
• Prior regulatory affairs experience in major markets is expected
• Prior experience in a management/leadership role is expected

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 $248,000 - $310,000 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.