Regulatory Affairs Vice President

This SF Bay Area biopharmaceutical company is developing medicines for patients who suffer from serious genetic diseases and cancers.  They are seeking a Vice President of Regulatory Affairs who can lead global regulatory strategies for the company, build out their Regulatory function, and manage a small team.  You will develop regulatory procedures and processes while helping to get transformative drugs approved.  This company offers a patient-first culture, flexible PTO, and the ability to work remotely (with some regular visits to their office.)  With one approved product and a program currently in Phase 2 trials, now an exciting time to join this growing organization!

Responsibilities:

  • Build, lead, and manage the global regulatory affairs function to ensure adherence to appropriate regulations and standards.
  • Provide leadership in creating and executing global regulatory strategies for product development, approval, and registration for portfolio of rare disease and oncology programs. May support other therapeutic areas as well.
  • Apply knowledge of global quality/regulatory standards and guidelines to ensure requirements are met across programs.
  • Serve as primary liaison with FDA and other regulatory authorities.
  • Partner with internal senior leadership to align closely on cross-functional global regulatory plans and the company’s short and long-term strategic objectives.
  • Provide leadership and oversight of the preparation of all critical global regulatory submissions (from pre-IND to post-marketing) to the FDA, EMA, and other international health authorities.
  • Oversee regulatory submission deliverables.
  • Represent Regulatory in senior management discussions. Present strategies, recommendations, and risks accordingly.
  • Hire and lead the Regulatory team by managing, mentoring, and teaching capabilities.
  • Work at both high-level strategic and hands-on in leading an agile team.
  • Develop standard operating procedures for global regulatory affairs and maintain internal and external documents.
  • Develop and maintain Regulatory Affairs department budget.

 

Qualifications:

  • Advanced degree such as PharmD, MD, or PhD preferred
  • A minimum of 15 years of Regulatory Affairs experience in the pharmaceutical industry, including expertise leading a Regulatory Affairs team.
  • Experience with Rare Disease programs required. Pediatric experience highly desired.
  • Must have track record of filing successful NDAs, BLAs, or MAAs.
  • Must have strong experience working directly with FDA and other health authorities.
  • Be well-versed in the drug development process and regulatory requirements, and have a good understanding of the underlying science.
  • Global/Ex-US Regulatory filing experience (EMA, Asia Pacific, etc) required.
  • Excellent written and verbal communication skills.
  • Excellent project management skills, with the ability to manage multiple projects and prioritize appropriately.
  • Ability to rapidly understand & analyze complex problems/situations.
  • Must have prior experience leading direct reports.
  • Strong interpersonal skills and the ability to effectively work with others. Ability to influence without authority and lead change.
  • Ability to lead teams under tight timelines and be willing to contribute significantly to day-to-day operations as needed.
  • Experience working with all levels of management and consulting with key business stakeholders (internal and external)
  • Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.

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