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Director, Regulatory Affairs

  • Location: San Francisco
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted 27 days ago

The Associate Director/Director, Global Regulatory Affairs will manage Clinical regulatory activities (including direct reports) for the oncology development program. This individual will represent Clinical Regulatory Affairs on project and submission teams and with global health authorities, and be responsible for timelines for IND/CTA and NDA/MAA submissions. Also responsible for ensuring that technical development programs are designed to meet regulatory requirements, and guide clinical-related programs to registration submissions and approvals.




Responsibilities:

  • Work closely with clinical and CMC development colleagues to develop regulatory submission strategies, review content, and maintain submission timelines to meet business objectives
  • Proactively identify regulatory issues and provide solutions to keep assigned programs on time, while maintaining the highest quality
  • Lead efforts for coordinating clinical content for original INDs, IND amendments, CTAs and NDAs
  • Work with department management on clinical plans for NDA/ MAA submissions and lead preparation and review
  • Take a lead role in preparations for Regulatory Agency meetings including drafting briefing documents with clinical focus
  • Participate in multidisciplinary efforts to prepare clinical updates for regulatory documents including
  • Review Investigator Brochures, Annual Reports, product labeling and Background Documents, safety submissions with a clinical focus
  • Work with regulatory organizations and partners in Europe and Asia to prepare applications and respond to queries to enable maintenance of clinical needs for clinical activities outside of the United States
  • Establish, manage, and maintain a knowledge base of current and emerging clinical regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues
  • Ensure communication and alignment on clinical regulatory strategy through partnership and communication with internal key stakeholders, including representing the regulatory department at strategy meetings
  • Assure compliance with regulatory standards and guidance documents
  • Prepare, submit, track, index, and archive electronic submissions
  • Ensure that clinical- related changes are reported to authorities in accordance with regulatory requirements
  • Conduct risk assessments of global clinical regulatory issues
  • Liaise with Medical Writing, contract CROs, and Regulatory Operations for coordinating and publishing submission documents
  • Manage department staff and vendors

Qualifications:

  • Bachelor's degree; Masters desirable (life sciences preferable)
  • 8+ years of clinical/CMC regulatory affairs experience required
  • Experience with the development (IND/ CTA) and registration (NDA/ MAA) stage
  • Experience with regulatory health authority interactions in North America and Europe
  • Experience with small molecule, oncology drug development desirable
  • Knowledge of the drug development process, drug laws, and global regulations and requirements
  • Strong analytical skills, problem solving ability and presentation skills required
  • Flexibility and ability to prioritize and manage multiple tasks simultaneously
  • Proven ability to manage projects
  • Highly effective oral and written communication skills
  • Broad background and ability to work and influence across multiple functions
  • Proficiency using Microsoft Office products and electronic systems is required; experience with documentation systems and publishing tools is a plus
  • Familiarity with project management principles is a plus



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