Regulatory Affairs Strategist for Clinical Trial Registration

hace 4 semanas


Barcelona, Barcelona, España Galderma A tiempo completo

Job Description:

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The Regulatory Affairs Strategist is responsible for delivering innovative global regulatory strategies for clinical trial registration with health authorities. This role oversees the regulatory aspects related to clinical trial submissions, aligning with the company's global business strategy and partnering with subject matter experts within the Global R&D.

Key Responsibilities:

  • Develop and manage clinical trial regulatory strategies for biologics, ensuring timely execution in line with agreed timelines, including responses to health authority queries, dossier amendments, SUSAR reporting, and other regulatory activities as needed.
  • Oversight of clinical trial regulatory submissions, guaranteeing accurate and compliant dossiers.
  • Archiving clinical trial documentation.
  • Managing health authority interactions for assigned regions in accordance with the agreed regulatory strategy.
  • Identifying and assessing risks associated with clinical regulatory submissions and recommending mitigation strategies.
  • Providing regular updates to the global regulatory lead and indication regulatory leads on specific clinical trials.
  • Management of outside vendors.

Requirements:

  • Detailed knowledge and understanding of regulatory requirements for pharmaceutical/biological product development.
  • Experience with performing regulatory submissions in at least one key regulatory region.
  • Ability to communicate regulatory strategies, issues, and risks in written and verbal formats to senior leadership and governing bodies.
  • Experience interfacing with regulatory agencies and implementing successful regulatory strategies.
  • Documenting regulatory strategies in coordination with clinical plans and marketing objectives.
  • Excellent team interaction skills and ability to work on a cross-functional team.
  • Capacity to identify opportunities/major issues and communicate impact.
  • Proven ability to adapt to rapid change.

What We Offer:

  • A competitive compensation package with a base salary of $120,000 per annum, inclusive of a performance-based bonus structure.
  • An extended benefit package, including comprehensive health insurance, retirement planning, and paid time off.
  • A hybrid work culture, offering flexibility and work-life balance.
  • Opportunities for career growth and professional development through feedback loops and personalized career paths.
  • A dynamic and inclusive work environment that values diversity, ownership, and accountability.


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