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Vice President of Regulatory Affairs

  • Job type: Permanent
  • Location: San Francisco
  • Salary: $250000 - $300000 per annum
  • Job reference: MLSN10518
  • Sector: EPM Scientific, Regulatory
  • Date posted: 05/01/2018
Job Summary
Our client is a privately held, clinical-stage biotech company that is developing the next generation of transformational immuno-oncology treatments. The Head of Regulatory Affairs will support this mission by overseeing all regulatory activities as well as developing and leading regulatory strategies for drug development and product registration within a growing organization. This individual will lead the company’s Regulatory Affairs group and will report directly to the Chief Executive Officer.

Position Responsibilities:

  • Provide regulatory strategic leadership for all drug development projects, including but not limited, to health authority submissions, interactions and other regulatory requirements in line with corporate objectives and timelines
  • Provide leadership, and when necessary, contribute hands on support to the regulatory team in managing, planning, coordinating, and preparing all documents submitted to FDA and ex-US health authorities in support of INDs, BLAs, MAAs, DMFs, CTAs, amendments, safety reports, and annual updates
  • Lead, grow and mentor the regulatory team, with a focus on career development.
  • Lead all interactions with regulatory agencies
  • Interpret and communicate regulatory expectations to internal and external stakeholders (including partners, CROs, CMOs, consultants, and contractors) in order to execute program objectives in compliance with applicable regulations
Education/Experience/Skills:
  • Minimum of ten years of experience in regulatory affairs within the biopharmaceutical industry
  • Experience with preparing regulatory documents including new INDs, safety reports, Investigator Brochures, DSURs, briefing packages and other regulatory submissions required
  • Experience with both early and late stage oncology drug development
  • Experience interacting directly with the FDA and other health authorities
  • Knowledge of FDA regulations and EU CTA requirements required
  • Strong leadership and communication skills and experience in working with multiple functional areas in a matrixed team environment required
  • Possess outstanding mentorship skills and promote the career development of members of the regulatory group
  • Experience with biologics and oncology products is essential, and immuno-oncology experience is a plus
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