Senior Manager - Regulatory Affairs

Employment Type:
Type of Job:
Regulatory Affairs
South East England
Salary Description:
UK Pound
Star Medical
Job Ref:

Senior Manager, Regulatory Affairs

Our client is a well-respected international healthcare leader with an exciting pipeline of upcoming launches; their people and performance are among the best in the world.

An exciting opportunity has arisen within Regulatory Affairs on a contract basis running until the end of 2020.

Are you an experienced pharmaceutical regulatory affairs professional, with biologics background and experience managing CMC changes? Then this is a fantastic opportunity to work on a high profile product range in a rapidly expanding pharmaceutical company

Key Responsibilities:

* Ensuring effective product maintenance and lifecycle management, in line with legal/regulatory requirements and regional business needs
* Responsible for ensuring effective implementation of filing plan, publishing and archiving of documents
* Planning, tracking, archiving of activities, especially submissions, internal memos and key correspondence.
* Effective planning and tracking of activities via internal system
* Leading regulatory activities in support of lifecycle management and maintenance in the region
* Supports coordination of the review of CMC, QRD, and labelling submissions and approval of product-related packaging as required to ensure regulatory compliance
* Notification of Regulatory activities and related database entry/data accuracy for allocated projects
* Cross-functional working with Global Regulatory teams

The ideal candidate will have/be:

* Graduate in Life Sciences
* 5+ years of regulatory affairs within pharmaceuticals
* A strong understanding of CMC activities within regulatory affairs
* Ideally, experience dealing with Biologic products

Apply now via this website!

Star is a full service resourcing and outsourcing company which resources at all levels for pharmaceutical, medical devices and technology, clinical research and healthcare communications companies in the UK and Ireland on a headcount and outsourced basis. If you haven't heard from us within 7 working days of submitting your application, please assume that you haven't been successful on this occasion. We wish you the best of luck with your job search.

You may return to your current search results by clicking here.

This website uses cookies. Read our cookie policy for more information. By continuing to browse this site you are agreeing to our use of cookies.

Latest Job Listings