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Director of Regulatory Affairs

2 months ago

Cambridge, Massachusetts, United States Sarepta Therapeutics Full time
Job Summary

Sarepta Therapeutics is seeking a highly experienced Regulatory Strategy Director to lead our regulatory affairs efforts. As a key member of our team, you will be responsible for developing and implementing regulatory strategies that ensure compliance with global regulations and facilitate the approval of our therapeutic programs.

Key Responsibilities
  • Develop and implement regulatory strategies for clinical and commercial therapeutic programs
  • Provide regulatory leadership for early research development products and conduct external regulatory due diligence activities
  • Work with cross-functional teams to ensure compliance with applicable global regulatory requirements
  • Facilitate identification and resolution of scientific and regulatory issues with regulatory agencies
  • Direct the preparation and submission of INDs, NDAs, and BLAs
  • Manage regulatory personnel and oversee responsibilities across the organization
  • May manage contractual and budgetary responsibilities with best business practices
  • Champion company goals regarding compliant commercial activities and integrate company goals into regulatory strategy
  • Participate in cross-functional leadership and non-therapeutic activities to increase capabilities across Sarepta
  • Enable a culture of compliance and support a strong regulatory infrastructure and SOPs
  • Sponsor/Lead 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 GPT 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 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