Overview

Reference Number: JO-2311-526394
Senior Regulatory Portfolio Manger
Rate: Negotiable
Job Type: Permanent
Location: Uxbridge

Senior Regulatory Portfolio Manager

Salary: £45.60 Per Hour PAYE

Contract Length: 12 month contract

Working Hours: 35 hours per week

Location: Uxbridge based – 2-3 days per week onsite

Cpl Life Sciences have partnered up with a well renowned Biopharmaceutical company to find an experienced individual within Regulatory Affairs. This company participates in the development and delivery of innovative medicines of serious and life threatening diseases. A successful applicant would be working with Regulatory Leads and wider Global Regulatory Sub-Team to deliver and execute the optimal regulatory strategy for assigned assets. In this role you would report directly to a Group Leader in Regulatory Portfolio Management.

Responsibilities:

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

Qualifications/Skillset & Experience required:

  • 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

If you feel this role would be a good fit or are interested in finding out more details about the role, please feel free to contact me via email at paul.adeyemi@cpl.com

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