About this role

  • Posted on

  • Location

    California, San Francisco

  • Salary

    £150000 - £200000 per annum

  • Type

    Permanent

  • Division

    Pharmaceutical Regulatory Affairs Jobs

  • Reference

    BBBH12707_1598460608

  • Start date

    ASAP

  • Managing this role

Harry Brown

Description

Director, Regulatory Affairs

San Francisco

$200,000 per annum + Benefits Package

Overview:

The Director, Regulatory Affairs will be responsible for several programs in the Oncology division, managing the filing and submissions for their early and late stage biological assets. The company has seen year on year growth with several programs already commercialised and others in the final stage of development. You will be joining at an exciting time with further plans to grow the department by another 7 in the first quarter of 2021.

Responsibilities:

  • Put together and manage document packages for regulatory submissions from development, manufacturing, preclinical and clinical areas including BLA’s, IND’s, and NDA’s.
  • Monitor, analyse, and act accordingly on intelligence for regulatory matters that may affect the company’s development programs
  • Support the development of innovative regulatory strategies for life cycle product management.
  • Drive cross-functional partnerships and builds consensus across various disciplines, including clinical development, research, manufacturing, business development, etc
  • Support the preparation and conduct of Agency meetings as necessary, including preparation and coordination of meeting requests and briefing packages.

Requirements:

  • 6+ years of regulatory affairs experience
  • Oncology experience
  • Minimum of Bachelor’s Degree
  • Experience in early and late-stage filings (BLA’s, INDs)

If this role is of interest, please apply to this with your updated Resume and someone will be in touch with you the same day to organize a time to speak. Alternatively, if you know someone in your network who may be interested in this position, please pass them over and if we end up placing them, we offer a generous referral fee.

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