Company:
Cpl Life Sciences
Location: Uxbridge
Closing Date: 02/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Job Title: Regulatory Portfolio Manager Job Type: 8-month contract PAYE (Inside IR35)
Uxbridge, UK – Hybrid/Remote
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; 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., Maintaining global submission plans including oversight of the interdependencies across regions for timely execution aligned with the asset’s priorities
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
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
Regulatory Portfolio Managers may also:
Degree or equivalent in healthcare related field
Direct regulatory experience with developing knowledge of US and/or EU procedures
able to lead through influence and building alignment with stakeholders to deliver projects to plan
3/5 years of experience in Regulatory Affairs
~ Strong Regulatory Strategy experience
~
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