Regulatory Portfolio Manager

3 days ago

Uxbridge, United Kingdom Proclinical Staffing Full time
Senior Regulatory Portfolio Manager

Proclinical Staffing is seeking a highly skilled Senior Regulatory Portfolio Manager to join our team. This role is a key part of our global regulatory strategy, working closely with our Regulatory Leads and the wider Global Regulatory Sub-Team to deliver and execute optimal regulatory strategies for assigned assets.

Key Responsibilities:
  1. Co-Lead Global Regulatory Sub-Team Meetings: Ensure high-quality discussions and decisions are made during Global Regulatory Sub-Team meetings.
  2. Develop and Maintain Regulatory Book of Work: Develop and maintain the asset's global regulatory book of work and Global Submission Plan.
  3. Track Regulatory Milestones: Track key regulatory milestones and liaise cross-functionally to generate periodic internal milestone reports.
  4. Support Regulatory Strategy Planning: Provide operational support on strategic global regulatory documents, including the Regulatory Strategy Plan.
  5. Coordinate Rapid Response Process: Coordinate the rapid response process to ensure quality and timely responses to health authority queries globally.
  6. Represent Global Regulatory Lead: Represent the Global Regulatory Lead in team meetings as needed.
  7. Support US Submissions: Coordinate preparation of regulatory components for US submissions and support preparations for FDA meetings.

Requirements:

  1. Degree in Healthcare-Related Field: Degree or equivalent in a healthcare-related field.
  2. Regulatory Experience: Direct regulatory experience with developing knowledge of US and/or EU procedures.

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