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Sr Director/VP Regulatory Affairs

ExecuNet Foster City Full-Time
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Reporting to the Chief Medical Officer, the Senior Director/Vice President, Regulatory Affairs

will serve as the global  regulatory  leader  for  defining  and  implementing  the  regulatory  strategy  across Company  product  pipeline.  He/she is responsible for the regulatory filing strategy for US FDA and all global interactions and filings, annual reports, as well as responses to requests from these agencies. In effect, this individual will provide regulatory leadership to cross functional teams ensuring effective communication with business partners and health authorities world-wide.

Primary Duties and Responsibilities

  • Provide regulatory  strategic  and  tactical  leadership  for  drug  development  projects,  including  health authority interactions, regulatory submissions and other regulatory requirements in line with corporate objectives, timelines and budgets.
  • Establish and  develop  regulatory  policies,  procedures  and  best  practices  commensurate  with  the requirements of a rapidly growing company.
  • Serve as  liaison  (single  point  of  contact)  with  FDA  and  other  Health  Authorities,  including  leading meetings and preparations to facilitate expedited approval of original applications and supplements, ensuring registration strategies adhere to corporate objectives.
  • Contribute and  lead  the  management,  planning,  coordination,  and  preparation  of  all  documents submitted  to  FDA  and other  Health  Authorities  in support of  INDs,  BLAs,  NDAs,  amendments,  safety reports, and annual updates.
  • Ensure completeness and accuracy of information provided in regulatory submissions.
  • Continually monitor  newly  published  FDA  guidelines  and  international  guidance  documents  in  the context of new and ongoing development programs.
  • Oversee preparation of regulatory presentations for clinical project team meetings and communicating project status and issues to executive management. Serve as the regulatory representative at project meetings and interacting with cross functional team to achieve corporate and study goals.
  • Develop and oversee the annual budget for the Department of Regulatory Affairs.

Qualifications

  • Advanced degree is preferred (MS/PhD/PharmD/MD)
  • 15+ years  industry  experience  in  regulatory  affairs  in  bio/pharma  industry  with  multiple  regulatory disciplines (preclinical, clinical, CMC, labeling, etc.).
  • Strong knowledge of FDA regulations and EU CTA requirements; direct oncology regulatory affairs with FDA and major health authorities preferred.
  • Delivery of a number of major applications (NDA/BLA, etc.) and lead role preferred.
  • Comfortable with setting strategies as well as taking a hands-on approach to all regulatory activities.
  • Experience with  preparing  regulatory  documents  including  new  INDs,  safety  reports,  Investigator Brochures, DSURs, PSURs, briefing packages and other regulatory submissions required.
  • Experience interacting/negotiating with regulatory authorities (e.g. FDA, EMA, etc.).
  • Working knowledge of electronic publishing/file management systems.
  • Strong leadership and communication skills and experience in working with multiple functional areas.
  • Prior experience in oncology, immunology, and targeted therapies would be a plus.
  • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance.
  • Ability to motivate and lead others.
  • Team player, ability to thrive in a collaborative and fast-paced environment and work well within cross-functional teams, maintain positive relationships with management, peers, subordinates and external partners.
  • Excellent oral and written communication skills.
  • Highly detailed oriented, well organized with the ability to prioritize multiple tasks to meet corporate deliverables.
 

Recommended skills

Non Disclosure Agreement (Intellectual Property Law)
Presentations
Attention To Detail
Team Working
Coordinating
Biologics License Applications (Bla)
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