Regulatory Affairs Portfolio Manager

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