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Job

VP, Regulatory Affairs (Oncology)

  • Location

    REMOTE

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Nikita Madan

  • Contact email:

    n.madan@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    21 days ago

  • Expiry date:

    2020-06-13

  • Startdate:

    ASAP

Vice President, Regulatory Affairs (Oncology)

Remote

 

Responsibilities:

  • Lead Global Regulatory Affairs and build out the Regulatory team
  • Ensures compliance with US and Global regulatory agencies and requirements
  • Build the regulatory strategy across the company’s product portfolio
  • Provide expertise and leadership in the development of regulatory approvals worldwise
  • Strategically assess which products in the development pipeline will be able to move through the regulatory process successfully
  • Lead interactions with global regulatory authorities and build relationships with regulatory agencies
  • Develop timelines and coordinate the activities of all departments towards achieving high-quality and on-time submissions.
  • Manage changes in product labeling.
  • Manage the provision of regulatory information to both internal and external customers through commercial communication.

 

Requirements:

  • 20+ years’ progressive related experience in drug development with at least 15 years in regulatory affairs.
  • Regulatory Affairs Professional Society (RAPS) certification preferred.
  • Graduate degree is preferred, but a bachelor’s degree is acceptable with additional experience.
  • Prior experience as a Director or above
  • Established relationships with regulatory agencies are desirable.
  • Excellent knowledge of the USA/EU regulatory pharmaceutical framework. Proven experience of achieving regulatory approvals in the USA and EU.
  • A commercial focus in the application of regulatory requirements.