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Job

Senior Director, Regulatory Affairs

  • Location

    San Francisco, CA

  • Sector:

    Life Sciences

  • Contact:

    Nikita Madan

  • Contact email:

    n.madan@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    2 months ago

  • Expiry date:

    2020-05-29

  • Startdate:

    ASAP

Senior Director Regulatory Affairs- San Francisco, CA

Specific Responsibilities and skills for Position

  • Leads all regulatory activities in line with regional requirements and company policies
  • Develops global regulatory strategies, recognizes and offers strategies to mitigate risks and influences project teams.
  • Prepares submissions and leads teams in preparation of submissions that require collaboration with other teams
  • Ensures knowledge of regulatory requirements are up to date, provides new regulatory guidance when possible, and conveys changes in regulatory information to project and management teams.
  • Obtains an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business. 
  • Responsible for creation and implementation of regulatory strategies and overseeing negotiations with regulatory bodies. 
  • Represents Regulatory Function at internal meetings and builds strong relationships with local Regulatory Authorities.
  • Reviews complex technical documents and influences colleagues across functions
  • Schedules and arranges own activities and those of direct reports.
  • Knowledge, Experience and Skills

  • Advanced Science Degree preferred (PhD, PharmD, MD, MSc)
  • 12+ years of overall regulatory experience
  • Global regulatory lead experience required
  • Management experience required
  • Experience in inflammation, rheumatology, immunology, or dermatology required