Job Title: Regulatory Portfolio ManagerJob Type: 8-month contract PAYE (Inside IR35)Location: Uxbridge, UK – Hybrid/RemoteRate: Up to £45.60 per hour PAYEAn 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-makingDevelop 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 reportsMaintaining global submission plans including oversight of the interdependencies across regions for timely execution aligned with the asset’s prioritiesCommunicate status and timeline changesProvide operational support to the GRL on strategic global regulatory documents including the Regulatory Strategy PlanCo-ordinate the rapid response process to ensure quality and timely responses to health authority queries globallyReview prior health authority queries to guide response developmentRepresent the Global Regulatory Lead in team as neededPartner with the US Regulatory Lead to:Co-ordinate preparation of regulatory components for US submissions and author assigned m1 documentsSupport and co-ordinate preparations for FDA meetingsProvide additional support e.g., precedent analysisRegulatory Portfolio Managers may also:Lead or represent RPM on GRS and enterprise process initiatives to drive a culture of continuous improvement and operational excellenceEngages with customers to enhance RPM supportDegree or equivalent in healthcare related fieldDirect regulatory experience with developing knowledge of US and/or EU proceduresAbility to work independently and at pace in a global matrix environment and effectively prioritizeStrong sense of personal accountability for delivery; able to lead through influence and building alignment with stakeholders to deliver projects to planContinuous improvement mindsetStrategic problem solverGood communication and negotiation skillsGood interpersonal skillsRequirements:MUST have a suitable degree in life sciences3/5 years of experience in Regulatory AffairsStrong Regulatory Strategy experienceIdeally someone who has worked on both pre and post approvalFull right to work in the UKFor more information please contact lucy.kirkaldy@cpl.com