Senior/Executive Director, Regulatory Affairs-Oncology


Senior/Executive Director, Regulatory Affairs, Oncology
Bay Area, CA

The Senior/Executive Director, Regulatory Affairs, Oncology will be responsible for providing global regulatory leadership in support of the development, registration, and life-cycle management of oncology products. He/she will ensure effective achievement of regulatory/business objectives across teams, within the department, and at the corporate level. As directed by the Vice President, the incumbent may assist in the organization and management of staff in the group, including coaching, career development, and overseeing the work. The Executive Director is responsible for defining, establishing and delivering regulatory requirements of oncology company product(s) in development, for regulatory filings from IND to BLA and beyond, including meetings, Investigator Brochures, Annual Reports, Post-Approval Supplements, Pharmacovigilance. Works collaboratively with other team members and subject matter experts in Marketing, Legal, Manufacturing, Quality, Clinical Development and Clinical Operations.

Essential Duties & Responsibilities:

  • Develop and implement competitive and effective global regulatory strategies for various oncology products including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies
  • Represent Regulatory Affairs, Oncology on various cross-functional teams and sub-teams to establish, advance and manage development and regulatory strategies for early through late stage development programs
  • As directed, will assist in organizing and managing staff in the group, including coaching, career development, and overseeing the work
  • Manage the evolution of oncology clinical development program strategies within changing regulatory environment and approval requirements
  • Manage, oversee, and 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 – these will include a variety of non-clinical, CMC and 
  • clinical documents
  • Maintain and communicate effective and timely regulatory intelligence and research, in support of regulatory affairs and oncology clinical development – Monitor current and evolving regulatory guidance, provide risk assessments and recommendations for various regulatory scenarios
  • Organize, facilitate and prepare for Health Authority meetings, meeting questions and requisite briefing documents
  • Effective team member on functional area and project team meetings, including nonclinical, clinical, and regulatory sub-teams as required
  • 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
  • Requirements:

  • 12-15 years of experience in biopharmaceutical industry or equivalent, with a minimum of 8 years in Regulatory Affairs
  • Bachelors degree; advanced degree preferred
  • Proven understanding of complex development strategies in oncology
  • As a member of interdisciplinary teams, ability to successfully manage multiple project deliverables, with ability to function independently in management of critical biopharmaceutical programs
  • Prior experience in managing direct reports, including coaching and career development
  • Experience preparing, managing and submitting major regulatory submissions through all phases of clinical development
  • Must be able to interpret and apply government regulations
  • Experienced with searching and evaluating regulatory intelligence and pharmaceutical
  • registration databases in support oncology product development and regulatory strategy
  • Superlative 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 others
  • Strong organizational and planning skills, as well as strong attention to detail
  • Accountable for results and goal attainment
  • Experience with electronic submissions requirements
  • 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 may require periodic travel (up to 10%) in the US
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Job Details

Job Type: Direct Placement
Location: Redwood City, CA
Job ID: 21-01553
Date Updated: February 17, 2021