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Director, Regulatory Affairs - Oncology Commercial

Company: Coherus BioSciences
Location: Redwood City
Posted on: February 20, 2021

Job Description:

Director, Regulatory Affairs - Oncology Commercial Title: Director, Regulatory Affairs - Oncology Commercial
Reports To: Vice President, Regulatory Affairs - OncologyLocation: Redwood City, CA
Classification: Exempt-- Overview: This position is responsible for the oncology commercial regulatory requirements of company product(s), and for regulatory intelligence activities that support the department. Responsible to establish review policies, review commercial materials (promotional and training materials), manage regulatory filings, including Annual Reports, Post-Approval Supplements, Change Control, Pharmacovigilance. The incumbent will establish and manage regulatory intelligence for the group. Responsible for developing strategies/timelines, conducting meetings, and acting as liaison with the Food and Drug Administration's Office of Prescription Drug Promotion (OPDP). Works collaboratively with other team members and subject matter experts in Marketing, Legal, Sales Operations, Manufacturing, Quality, Clinical Development and Medical Affairs. Note:--The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title:

  • In support of commercial products, develop, prioritize, execute, and provide guidance for effective, proactive commercial regulatory strategies and plans
  • Work effectively with Commercial Team on post-approval supplements, line extensions, change control and necessary regulatory filings to support commercial products (eg Annual Reports, Development Safety Update Reports, Investigator Brochures, Post-Approval Supplements) 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
  • Interface with other team leaders to ensure coordination and implementation of consistent standards and processes
  • Ensure quality submissions, including proofreading documents and working closely with Regulatory Operations to publish the final regulatory OPDP submissions
  • Interact with key personnel in OPDP as needed
  • 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:
    • 10 years of experience in biopharmaceutical industry or equivalent, with a minimum of 5 years in Regulatory Affairs
    • Must be able to interpret and apply government regulations
    • 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
    • Excellent and effective written and oral communication skills, including presentation skills and interpersonal skills
    • Exceptional cross-functional team leadership skills, and ability to work in close collaboration with other
    • Strong organizational and planning skills, as well as strong attention to detail
    • Accountable for results and goal attainment
    • 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
    • Strong computer skills in Word, Access and Adobe Acrobat and working knowledge of electronic publishing/file management
    • This position will require periodic travel (up to 10%) in the US If you had selected 'Other', please provide more details below
      If you had selected 'Referral', please provide more details below

Keywords: Coherus BioSciences, Redwood City , Director, Regulatory Affairs - Oncology Commercial, Healthcare , Redwood City, California

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