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Job

Director of Regulatory Affairs

  • Location

    San Francisco, California

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    CORTLAND HOTZ

  • Contact email:

    c.hotz@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    25 days ago

  • Expiry date:

    2020-12-01

  • Startdate:

    ASAP

Director of Regulatory Affairs

Location: San Francisco

Type: Full Time Permanent 

Salary: Excellent salary, bonus and accompanying benefits package

Stellar opportunity with a clinical stage biopharma company focused in oncology and auto-immune diseases. This company has multiple promising drugs in their pipeline. In this role you would be responsible for constructing global development plans for this their portfolio of early stage products. Enthusiasm for this client’s portfolio as well as previous regulatory experience similar to their pipeline will make a strong candidate!

Responsibilities
 

  • Development global regulatory strategy and provide operational leadership for regulatory activity
  • Defines strategies for IND’s, DMF’s, NDA’s
  • Work cross functionally with teams throughout the organization – advise on regulatory topics
  • Liaison with major health authorities - US FDA, EMA, and others
  • Understands and imposes regulatory requirements in compliance with government agencies
  • Strong relationship builder to optimize workflow
  • Builds and manages relationships with key stakeholders
  • Problem solver and thinks ahead for the future of the company/department
  • May be responsible for the build out of the regulatory team.
  • When applicable - train direct and indirect reports

Qualifications
 

  • Bachelor's degree required, advanced degree is a plus
  • ~8 years of applicable experience in a leadership role
  • Oncology experience preferred
  • FDA and EU regulatory experience is required
  • Proven success in gaining regulatory approval
  • Experience with INDs, CTAs, DMFs, and briefing packages
  • Familiarity with CMC, Pharmacovigilance and Quality
  • Demonstrated leadership ability and experience managing, coaching, and mentoring
  • Exceptional relationship-building skills with internal and external stakeholders
  • Excellent verbal and written communication skills
  • Successful management of projects to completion meeting budgets and timelines

 

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