Overview
Reference Number: JO-2311-525806
Senior Regulatory Portfolio Manager
Rate: Negotiable
Job Type: Contract
Location: Uxbridge
Senior Regulatory Portfolio Manager
12 month contract
Hybrid working from Middlesex (2 days per week)
Offering up to £45.00 Per Hour via PAYE
CPL Life Sciences is collaborating with a leading pharmaceutical organisation developing innovative medicines in Oncology, Haematology and Cardiology who are looking for a Regulatory Portfolio Manager to support global regulatory strategies. Partnering with the Global Regulatory Lead you will be responsible for executing regulatory strategy across the FDA and EU affiliates.
Job Responsibilities include;
– Tracking key regulatory milestones., health authority meetings, post-approval commitments, annual reports.
– 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
– Co-ordinate preparation of regulatory components for US submissions and author assigned m1 documents
– Support and co-ordinate preparations for FDA meetings
– Enterprise process initiatives to drive a culture of continuous improvement and operational excellence
Candidate Requirement Include;
– Must be eligible to live and work in the United Kingdom
– Life Sciences Degree or equivalent qualification
– Direct regulatory experience with developing knowledge of US and/or EU procedures
– Strategic problem solver
– Good communication and negotiation skills
If this role is of interest to you please forward your up to date CV to sophie.malyon@cpl.com.
