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Job

Associate Director/ Director of Regulatory Affairs

  • Location

    Redwood City, CA (REMOTE FLEX)

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Jessica Figueroa

  • Contact email:

    j.figueroa@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    4 months ago

  • Expiry date:

    2021-08-31

  • Startdate:

    ASAP

Overview:

  • Commercial product company
  • Larger biologics company that focuses on oncology
  • Recently bought a immunoncology product
  • Currenlty at the BLA submission phase in their pipeline
  • Looking for someone to develop ans spearhead that product that is in late stage

Job Description:

  • Collaborative regulatory lead for oncology project teams and sub-teams, effectively contributing to team regulatory submissions (eg (pre)-IND, Protocols, Investigator Brochures, (pre)-BLA, Type C, Annual Reports, Post-Approval Supplements, Change Control, Pharmacovigilance) and business deliverables
  • Work effectively with Commercial Team on post-approval supplements, line extensions, change control and necessary regulatory filings to support commercial products and post-marketing commitments for both the US and EU
  • Manage the regulatory aspects of promotional materials (press releases, website, social medial review, etc), as well as sales training materials
  • Support post-marketing activities for commercial products, including review and approval of commercial labeling and advertising/promotional materials, based on domestic and international regulatory requirements
  • Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact the Company’s promotion of products and operations – Advise personnel in other departments regarding their applicability and impact
  • Update and provide appropriate promotional compliance and regulatory training and education to contracted staff (eg contracted physicians, speaking on behalf of company)

Requirements:

  • 8 - 10 years of experience in biopharmaceutical industry or equivalent, with a minimum of 5 years in Regulatory Affairs
  • Bachelors degree; advanced degree preferred
  • Experience in establishing and managing regulatory intelligence through search evaluation and distillation of regulatory and oncology clinical data sources
  • Experience and a thorough understanding of the preparation of promotional material and the translation of regulatory requirements into practical plans
  • Exceptional cross-functional team leadership skills, and ability to work in close collaboration with other
  • Experience with electronic submissions requirements and the review of promotional materials prepared in support of regulatory filings
  • Ability to work independently with limited supervision, adapt to change and manage multiple tasks
  • Ability to problem-solve and make decisions on complex issues, often in a cross-functional team setting
  • Technical knowledge of US regulations and ICH and GXP Guidelines
  • This position will require periodic travel (up to 10%) in the US

I manage a range of other permanent and freelance positions for a broad portfolio of clients (Biotech, CRO and Pharma). 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. Contact Jessica Figueroa 619-326-3672 or j.figueroa@hamlynwilliams.com