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Job

Senior Director Regulatory Affairs

  • Location

    San Diego

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    Ryan Shaffer

  • Contact email:

    r.shaffer@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 1 month ago

  • Expiry date:

    2019-11-07

  • Startdate:

    ASAP

Job Description:

  • Prepare and execute worldwide regulatory strategies/plans, both short term and long term
  • Manage regulatory team with oversight for day to day department responsibilities
  • Lead and participate in regulatory strategy formulation working closely with Clinical, Market Access, R&D, and Quality teams.
  • Generate or direct regulatory affairs specialists in the preparation of submissions (i.e. IND, NDA, BLA, supplements, product registrations, etc.) to obtain various worldwide approvals to commercially distribute products
  • Oversee the subsequent submissions (annual reports, change notifications, etc.) to facilitate the maintenance of these approvals
  • Present project updates during team meetings and updates to senior management
  • Provide on-going support to product development
  • Participate or direct the staff in the engineering change order process, by reviewing engineering and manufacturing document release and changes
  • Review and provide input to labelling and marketing programs in reference to regulatory requirements
  • Keep abreast of new developments regarding various regulations and advise senior management as necessary
  • Interface with regulatory agency representatives as needed to accomplish the above tasks

 

If you are interested in more information, please reach out to Ryan at 347-305-6781 or r.shaffer@hamlynwilliams.com