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

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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 [email protected]