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Job

Senior Director of Regulatory Affairs

  • Location

    Los Angeles, CA

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    CORTLAND HOTZ

  • Contact email:

    c.hotz@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    28 days ago

  • Expiry date:

    2020-11-22

  • Startdate:

    ASAP

Senior Director of Regulatory Affairs

Location: Los Angeles, CA

Type: Full Time Permanent 

Salary: Excellent salary, bonus and accompanying benefits package

Our client is a large and growing biotech company with promising oncology candidates throughout their pipeline. As a representative of the regulatory function you will provide essential leadership in support of their development programs. Strong candidates have proven industry successes with regulatory document submissions to Health Authorities for oncology products.  Additionally, oncology drug development experience is highly desired.


Responsibilities:

  • Produce regulatory product strategies
  • Represent the regulatory function on cross-functional development teams
  • Identify and assess regulatory risks, mitigations, and contingencies
  • Plan, prepare, and review submissions including FDA, EMA and other national authorities
  • Lead and oversee regulatory activities for assigned projects
  • Manage the regulatory aspects of products and projects
  • Ensure that regulatory documents confirm compliance with regulatory requirements
  • Serve as the Global Regulatory Leader for assigned Product Teams
  • Work cross functionally to provide advice regarding regulations
  • Accountable for robust meeting requests, briefing documents, and preparation of teams for meetings
  • Accountable for responses to regulatory authorities
  • Mentor and coach other regulatory affairs personnel
  • Work externally to when needed
     

Requirements:

  • MS/PhD/PharmD in a scientific discipline is preferred
  • ~12 years' experience in industry related Regulatory Affairs
  • Experience in the preparation and submission of regulatory documents
  • Demonstrated experience in leading a team to prepare for major health authority interactions
  • Experience with investigational drugs, including late stage development, and marketed products, to include submissions of BLA/NDAs
     

My team and I manage a slew of other full-time and contract positions for large, mid-size, and start up companies across the US (Pharma, Biotech, and Medical Device). If the above role isn’t for you but you’d nevertheless like to discuss your options in the market, I’d welcome a confidential discussion by phone or email. Please feel to reach out directly: (619) 350 - 6195 and/or c.hotz@hamlynwilliams.com