Regulatory Portfolio Manager

3 days ago


South East England, United Kingdom Cpl Life Sciences Full time £46
Regulatory Portfolio Manager

Cpl Life Sciences is seeking a highly skilled Regulatory Portfolio Manager to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in delivering and executing the optimal regulatory strategy for assigned assets.

Key Responsibilities:
  • Partner with the Global Regulatory Lead and wider Global Regulatory Sub-Team to develop and maintain the asset's global regulatory book of work and Global Submission Plan.
  • Track key regulatory milestones and maintain global submission plans, ensuring timely execution aligned with the asset's priorities.
  • Provide operational support to the GRL on strategic global regulatory documents, including the Regulatory Strategy Plan.
  • Coordinate the rapid response process to ensure quality and timely responses to health authority queries globally.
  • Represent the Global Regulatory Lead in team meetings as needed.
Requirements:
  • Degree or equivalent in a healthcare-related field.
  • Direct regulatory experience with developing knowledge of US and/or EU procedures.
  • Ability to lead through influence and build alignment with stakeholders to deliver projects to plan.
  • 3-5 years of experience in Regulatory Affairs.

Why Cpl Life Sciences? We are a leading pharmaceutical business with a strong commitment to regulatory excellence. Our team is dedicated to delivering high-quality results and making a positive impact in the industry.



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