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VP Global Regulatory Strategy Apply to This Job

Company: ExecuNet
Location: San Diego
Posted on: February 23, 2021

Job Description:

The Vice President of Global Regulatory Strategy is a leadership position that drives development, alignment, and implementation of global regulatory strategies that support marketing applications with optimal product labelling in global markets. The role is responsible for building and maintaining an excellent working relationship with the FDA, partnering with Regulatory International to support relationships with the EMA and national competent Health Authorities in the EU, ensuring global regulatory compliance, and overseeing submissions and approvals of dossiers supporting the portfolio in the US. This role facilitates collaboration between colleagues in San Diego, Boston and Zug on Regulatory operational processes. The incumbent will manage Global Regulatory Leads on project teams, be a member of the RA Leadership Team, and act as a key contact for critical business units within R&D and Commercial.

What you'll dive into

  • Lead development and implementation of registration pathways for all product candidates, considering registration requirements, data gaps, regulatory risk, and associated market access challenges
  • Lead gap analyses of global registration plans; manage regulatory risks to ensure alignment of US and ex-US negotiation and mitigation strategies and regulatory planning activities
  • Proactively support the development of target product profiles and intended labels
  • Provide strategic input to program teams and Global Regulatory Leads to identify regulatory pathways to approvability of marketing applications and successful IND/CTA trial applications
  • Lead interactions with regulatory consultants/advisors for strategic input, as needed
  • Ensure alignment with and support of global market access needs
  • Monitor US regulatory guidelines and trends and communicates appropriately to key stakeholders
  • Work effectively with clinical, market access, medical, pharmacovigilance, quality and commercial functions to develop effective medical strategies, attain clinically meaningful and commercially viable labels, and achieve appropriate pricing and reimbursement
  • Oversee preparation of health authority meeting materials to ensure alignment of global strategies
  • Lead and oversee meetings with the FDA; engage in the management of meetings with other health authorities
  • Contribute to and review responses to health authority queries with primary focus on preclinical and clinical issues to ensure appropriate, consistent and complete responses that are aligned with global development strategy
  • Ensure the establishment and maintenance of strong relationships with FDA project managers
  • Support all submissions planning processes in collaboration with Global Regulatory Leads, Document Operations, and Regulatory Operations
  • Deliver approvable NDAs, PSPs, and Orphan Designations
  • Work closely with Global Regulatory Leads and Regulatory Operations to ensure collaboration with EU RA operational processes for publishing and CTA preparation and submission What we expect
    • BS or MS degree in a scientific discipline with minimum 20 years of regulatory and drug development experience across all phases (1-4); advanced degree (MD, PhD, PharmD) preferred
    • Significant experience in a leadership role with multiple NDA/MAA submissions and approvals
    • Experience in a leadership role with health authority negotiations in multiple regions
    • Experience with brand optimization strategies and commercial awareness
    • Demonstrated ability to analyze and interpret efficacy and safety data
    • Strong understanding of regulatory operational activities
    • Demonstrated proficiency in people management
    • Outstanding management, interpersonal, communication, negotiation and problem-solving skills
    • Demonstrated proficiency in organizational awareness, including experience working cross-functionally and on global matrixed teams
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Keywords: ExecuNet, San Diego , VP Global Regulatory Strategy Apply to This Job, Executive , San Diego, California

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