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Job

Associate Director/Director, International Regulatory Affairs

  • Location

    San Francisco

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Nikita Madan

  • Contact email:

    n.madan@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    26 days ago

  • Expiry date:

    2020-07-10

  • Startdate:

    ASAP

Seeking a regulatory professional who will be responsible for leading the global regulatory strategy for expansion of our development product(s) into international markets.

Responsibilities

  • Develop global regulatory strategy (including clinical/nonclinical, CMC and global labeling) for product(s)that are in alignment with overall global product strategy, market timing plans and corporate goals
  • Participate/lead regional health authority meetings
  • Lead preparation of regulatory documentation especially clinical/nonclinical content for global markets in partnership with Regulatory regional leads and GRL
  • Lead the development of global dossier strategy to support international marketing applications for assigned product
  • Participate/lead relevant functional area and project team meetings

 

Experience/Skills

  • 10-15years of industry experience in Regulatory Affairs or a related discipline
  • Prior experience as a Global Regulatory Lead
  • Ability to develop and maintaining strong connections with regional and country leads
  • Regulatory information expert with prior experience developing product approval strategies
  • Proven track record of managing critical projects as a part of an interdisciplinary team
  • Prior experience managing regulatory submissions to deadlines
  • Experience managing a small team or at a minimum management in a matrix setting

 

Education

• BA/BS degree in life sciences
• Advanced degree a plus