VP / SVP Regulatory

Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Vice President, Regulatory Affairs will report to the Chief Development Officer and help forward Priovant’s mission by leading the execution of global regulatory strategies across our multiple late-stage programs. This is a hands-on role that requires a strong working knowledge of regulatory procedures and a proven track record leading successful NDA/Global submissions and post-approval procedures. Candidates must be able to thrive in a high energy, small-company, entrepreneurial environment, and be comfortable developing and implementing innovative regulatory approaches.

Responsibilities

• Draft, review, and submit high-quality documentation for INDs, CTAs, NDAs, MAAs, pediatric plans and related filings to regulatory agencies, consistent with corporate goals, including original applications and product maintenance such as amendments and annual reports
• Provide hands-on leadership of cross-functional teams (non-clinical, clinical, CMC, biostatistics) to drive preparation, review, submission and approval of regulatory filings
• Lead a team responsible for scientific and tactical regulatory strategy, operations submissions, and approvals throughout the drug development life cycle
• Work with a cross-functional team on labelling, risk management, pharmacovigilance and post-marketing requirements
• Identify opportunities to utilize accelerated development approaches and novel endpoints to speed up development timelines; work with regulatory agencies to gain buy-in on these approaches
• Track regulatory commitments and deliverables while coordinating with internal and external staff to ensure timely submissions
• Interact with consultants and manage external regulatory writing support, as necessary
• Ensure regulatory requirements and strategy are understood by project teams
• Serve as FDA and EMA liaison and provide leadership and support for regulatory agency meetings and teleconferences for assigned programs
• Maintain up-to-date knowledge on international and domestic regulatory requirements

Qualifications

• PharmD, PhD or MD preferred
• 10+ years of biopharma Regulatory Affairs experience, including extensive experience with the preparation and submission of INDs and NDAs/BLAs, global submissions and label negotiations.
• Must have led or been a significant contributor to at least 2 successful NDAs for novel therapies (rare disease experience strongly preferred) and significant post-approval experience with those programs.
• Must have significant inspection readiness and inspection experience
• Must have small company experience and thrive in an innovative, agile, and entrepreneurial environment, with ability to effectively collaborate and perform well under pressure
• Strong working knowledge of global pharmacovigilance principles and requirements
• Experience successfully navigating the Advisory Committee process preferred
• Experience with commercial Regulatory Affairs, including label expansion for new indications
• Deep knowledge of GxP regulations and ICH and FDA guidance and regulations.
• Experience with small molecule development programs, particularly late stage/commercial
• Experience with expedited pathways
• Therapeutic area experience in immunology and autoimmune diseases preferred
• Experience with EU Clinical Trial Regulation and Clinical Trial Information System
• Ability to quickly assimilate technical and scientific information and consistently produce thorough and accurate work
• Desire to be part of a regulatory organization that generates strategic value through creative approaches
• Able to balance strategic initiatives with hands-on work of drafting submissions, correspondence, and internal policies/procedures, with a high sense of urgency and drive for results
• Demonstrated communication, problem-solving, and decision-making skills
• Natural collaborator who enjoys working on a cross-functional team

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