Regulatory Affairs Portfolio Manager

2 months ago

Uxbridge, United Kingdom Cpl Life Sciences Full time

Job Title: Regulatory Portfolio Manager

Job Type: 8-month contract PAYE (Inside IR35)

Location: Uxbridge, UK – Hybrid/Remote

Rate: Up to £45.60 per hour PAYE


An exciting opportunity to join a leading pharmaceutical business on a contract basis.


The Regulatory Portfolio Manager partners with Regulatory Leads and wider Global Regulatory Sub-Team to deliver and execute the optimal regulatory strategy for assigned assets. The role reports directly to a Group Leader in Regulatory Portfolio Management.

  • Partner with the Global Regulatory Lead (GRL) and wider Global Regulatory Sub-Team (GRST) to deliver and execute the optimal regulatory strategy for assigned asset(s):
  • Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions; diligent 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 as defined by the GRST., health authority meetings, post-approval commitments, annual reports, etc.
  • Liaise cross-functionally to generate periodic internal milestone reports
  • Maintaining global submission plans including oversight of the interdependencies across regions for timely execution aligned with the asset’s priorities
  • Communicate status and timeline changes
  • Provide operational support to the GRL on strategic global regulatory documents including the Regulatory Strategy Plan
  • Co-ordinate the rapid response process to ensure quality and timely responses to health authority queries globally
  • Review prior health authority queries to guide response development
  • Represent the Global Regulatory Lead in team as needed


Partner with the US Regulatory Lead to:

  • Co-ordinate preparation of regulatory components for US submissions and author assigned m1 documents
  • Support and co-ordinate preparations for FDA meetings
  • Provide additional support e.g., precedent analysis


Regulatory Portfolio Managers may also:

  • Lead or represent RPM on GRS and enterprise process initiatives to drive a culture of continuous improvement and operational excellence
  • Engages with customers to enhance RPM support
  • Degree or equivalent in healthcare related field
  • 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; able to lead through influence and building alignment with stakeholders to deliver projects to plan
  • Continuous improvement mindset
  • Strategic problem solver
  • Good communication and negotiation skills
  • Good interpersonal skills


Requirements:

  • MUST have a suitable degree in life sciences
  • 3/5 years of experience in Regulatory Affairs
  • Strong Regulatory Strategy experience
  • Ideally someone who has worked on both pre and post approval
  • Full right to work in the UK


For more information please contact lucy.kirkaldy@cpl.com

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