Regulatory Affairs Portfolio Manager

2 days ago

Uxbridge, United Kingdom Cpl Life Sciences Full time
Job Description

Job Title: Regulatory Affairs Portfolio Manager

Job Type: Contract

Location: Remote/Hybrid

Rate: Up to £45.60 per hour

Cpl Life Sciences is seeking a highly skilled Regulatory Affairs Portfolio Manager to join our team on a contract basis.

Key Responsibilities:

  • Partner with the Global Regulatory Lead and wider Global Regulatory Sub-Team to deliver and execute the optimal regulatory strategy for assigned assets.
  • Co-lead GRST meetings to ensure high-quality discussions and decisions, and follow up with sub-team members to uphold accountabilities and drive decision-making.
  • Develop and maintain the asset's global regulatory book of work and Global Submission Plan, including tracking key regulatory milestones and liaising cross-functionally to generate periodic internal milestone reports.
  • Maintain global submission plans, including oversight of interdependencies across regions for timely execution aligned with the asset's priorities.
  • Communicate status and timeline changes, and provide operational support to the GRL on strategic global regulatory documents.
  • Coordinate the rapid response process to ensure quality and timely responses to health authority queries globally.
  • Review prior health authority queries to guide response development, and represent the Global Regulatory Lead in team as needed.

Key Skills and Qualifications:

  • Direct regulatory experience with developing knowledge of US and/or EU procedures.
  • Ability to work independently and at pace in a global matrix environment and effectively prioritize.
  • Strong sense of personal accountability for delivery, and ability to lead through influence and building alignment with stakeholders to deliver projects to plan.
  • Continuous improvement mindset, strategic problem-solving skills, and good communication and negotiation skills.
  • MUST have a suitable degree in life sciences, 3/5 years of experience in Regulatory Affairs, and strong Regulatory Strategy experience.
  • Ideally someone who has worked on both pre and post-approval, and full right to work in the UK.

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