Accessibility Links

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
Similar jobs
Quality Engineer
  • Job type: Permanent
  • Location: Rochester, New York
  • Salary: Competitive
  • Description Title: Quality Engineer Salary: $60,000 - $80,000 + Benefits + Excellent Career Growth A medical device company that manufactures, develops, and markets minimally invasive surgical instruments is
Sr. Quality Manager GCP
  • Job type: Permanent
  • Location: Cambridge, Massachusetts
  • Salary: US$110000 - US$140000 per annum
  • Description Title: Sr. Quality Manager, GCP Salary: $110,000 - $140,000 + Bonus + LTI + Benefits Company Summary: One of the top global pharmaceutical companies is looking for a Sr
Head of Quality (QA/QC)
  • Job type: Permanent
  • Location: Walkersville, Maryland
  • Salary: Negotiable
  • Description Title: Head of Quality QA/QC Salary: $185,000 - $200,000 + Bonus + Benefits Company Summary: One of the top global suppliers to pharmaceutical, biotechnology, and speciality ingredient markets is
Head of Drug Safety & Pharmacovigilance
  • Job type: Permanent
  • Location: San Francisco, California
  • Salary: Negotiable
  • Description Head of Drug Safety & Pharmacovigilance Head of Drug Safety & Pharmacovigilance San Francisco, California A late-stage biopharmaceutical company focused on discovering, developing
Associate Director Signal Management
  • Job type: Permanent
  • Location: Boston, Massachusetts
  • Salary: Negotiable
  • Description Associate Director Signal Management Associate Director Signal Management Greater Boston area A pharmaceutical leader that focuses on developing and manufacturing world-class innovative medicines