Senior Manager - Regulatory Affairs
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
- 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.