Senior Regulatory Affairs Manager

Vor 4 Tagen


Zug, Zug, Schweiz Michael Page Vollzeit
About the Role

We are seeking a highly skilled Senior Regulatory Affairs Manager to join our team at Michael Page. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and providing strategic guidance on regulatory matters.

Key Responsibilities
  • Regulatory Strategy and Planning
    • Develop and implement regulatory strategies to support business objectives
    • Collaborate with cross-functional teams to ensure regulatory compliance
  • Regulatory Vendor Management
    • Oversee regulatory vendors to ensure successful execution of operational activities
    • Establish and manage key performance indicators (KPIs) for vendor performance
  • Regulatory Contract Management
    • Manage and oversee regulatory contracts, statements of work (SOWs), and purchase orders (POs)
    • Work closely with procurement, finance, and medical operations teams to ensure compliance
  • Regulatory Submission and Filing
    • Plan and implement regulatory strategies for assigned projects and programs
    • Coordinate and file all necessary regulatory submissions
  • Regulatory Training and Support
    • Provide training and support to regulatory colleagues, in-country RA leads, and vendors
    • Ensure in-country RA leads receive necessary training and support
Requirements
  • 6 to 8+ years of experience in the pharmaceutical or biotechnology industry with 4 to 6+ years of regulatory experience
  • Strong knowledge of applicable regulations and submission standards/requirements
  • Ability to interpret regulations and guidelines
  • Experience in preparing regulatory submissions and supportive amendments or supplements
  • Strong communication and project management skills in global and virtual teams
  • Strong interpersonal skills and ability to collaborate effectively across project teams and external stakeholders
  • Ability to work independently with minimal supervision
  • Strong organizational skills to prioritize workload and manage complex tasks
What We Offer

As a Senior Regulatory Affairs Manager at Michael Page, you will have the opportunity to work with a talented team of professionals and contribute to the success of our organization. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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