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Director of Regulatory Affairs

Posted 24 days ago

  • Sector: Pharmaceutical, Biotech
  • Contact: Stefanni LaJeunesse
  • Contact Email:
  • Expiry Date: 12 May 2021

In this role, you would be responsible for delivering on oncology clinical and commercial regulatory requirements of company biologics, and for managing regulatory activities that support the department. You would lead, manage, and support clinical development activities and submissions for oncology products, participate on various product development teams and sub-teams, manage regulatory filings, establish review policies, review commercial materials (promotional and training materials). You will develop strategies/timelines, conduct meetings, and act as liaison with the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP).

Responsibilities for Director of Regulatory Affairs:

  • 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

  • Ensure submissions to regulatory health authorities are complete, well-organized, of high quality, and compliant, working in concert with subject matter experts, external vendors and with Regulatory Operations

  • Perform and manage effective and timely regulatory intelligence and research, in support of regulatory affairs and oncology clinical development

  • Keep current on the FDA OPDP environment and competitive products; communicate such environment to the teams

  • Monitor current and evolving regulatory guidance, provide risk assessments and recommendations for various regulatory scenarios

  • 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)

  • Provide appropriate promotional compliance and regulatory training and guidance to sales reps and medical science liaisons regarding their respective roles and responsibilities

Requirements for Director of Regulatory Affairs:

  • Bachelors degree; advanced degree preferred

  • 10 years of experience in biopharmaceutical industry or equivalent, with a minimum of 5 years in Regulatory Affairs

  • 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

  • Experience with electronic submissions requirements and the review of promotional materials prepared in support of regulatory filings

  • Technical knowledge of US regulations and ICH and GXP Guidelines

  • Strong computer skills in Office, Access and Adobe Acrobat and working knowledge of electronic publishing/file management

  • This position will require periodic travel (up to 10%) in the US