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Regulatory Affairs Manager

2 months ago

South San Francisco, United States Rangam Full time

Hybrid-Role


This is not a remote role but manager is open for remote candidates who can come onsite on need basis

  • First inhuman solid heme space
  • Should know What should be the GO strategy for in human studies
  • Exp on sponsor side needed
  • INDs and CTAs and amendments
  • Exp in early oncology to lead team
  • Lead early oncology programs as lead
  • IND, CTA submission
  • 5 – 7 (assoc dir)/ 7 – 9 (director) years of experience in Regulatory Affairs (strong preference for experience in oncology)
  • CRO exp does no have strategy piece
  • Inhuman studies in solid tumour space
  • Exp in leading regulatory strategy in global in human oncology space

This position is based at South San Francisco, CA location.

  • We are currently seeking a Regulatory Affairs Associate Director/Director to join our growing regulatory team. In this role you would be the Global Regulatory Lead where you will develop and implement global regulatory strategies to support the development of multiple oncology early development assets, contributing to the advancement of leading edge cancer research in a nimble, biotech like environment within a large, well established pharmaceutical company.
  • This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables.

Key Responsibilities:

  • Serve as the Global Regulatory Lead on project teams and key sub-teams
  • Develop and implement competitive and effective global regulatory strategies for oncology products including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies
  • Provide advice and guidance to project teams on the interpretation and application of relevant regulatory requirements and review processes
  • Collaborate with Client regional and country regulatory affiliates to support ex-US clinical development activities
  • Present Regulatory strategies and issues at team and governance meetings
  • Serve as primary Health Authority contact for assigned projects and foster positive and effective working relationships between project team members and Health Authority reviewers
  • Prepare teams for and lead Health Authority meetings
  • Manage and participate in the creation, review, assembly and submission of regulatory documents including INDs and CTAs and amendments, RFIs, annual reports
  • Ensure consistency/completeness/adherence to standards for all regulatory submissions
  • Coordinate and consult with other departments on the content, review of publication materials, and assembly of regulatory documentation
  • Support non-program specific projects as assigned such as department initiatives, business development assessments, clinical assessments, and department training, etc.

Qualifications:

  • Bachelor degree in a life sciences, chemistry, or related discipline. Advanced degree preferred.
  • 5 – 7 (assoc dir)/ 7 – 9 (director) years of experience in Regulatory Affairs (strong preference for experience in oncology) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment. International regulatory experience required.
  • Demonstrated understanding of regulations and guidelines governing oncology drug development and ability to strategically apply to overall drug development
  • Demonstrated leadership ability in team settings
  • Strong written and verbal communication skills
  • Demonstrate expertise and knowledge of oncology and relevant indications

Key Leadership Competencies:

  • Builds strong relationships with peers and with partners cross functionally outside of team to enable higher performance
  • Learns fast, grasps the 'essence' and can change the course quickly where indicated
  • Raises the bar and is never satisfied with the status quo
  • Creates a learning environment, opens to suggestions and experimentation for improvement
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality