Regulatory Affairs Specialist
Location: Sandwich, Kent
Contract: 12 Month Contract
Hours: Full-time
About the Role
Our Client is seeking a highly organized and detail‑oriented Regulatory Affairs Specialist to join their Global Regulatory and International Operations team. This role is responsible for the operational management and delivery of regulatory submissions to Health Authorities across multiple regions. Working within a fast‑paced and highly regulated environment, you will support the planning, coordination and execution of regulatory dossiers, ensuring compliance with global standards and tight submission deadlines.
Key Responsibilities
- Coordinate regulatory submission activities for assigned products and markets
- Plan and manage the preparation and delivery of regional and national regulatory dossiers
- Liaise with project teams and global stakeholders to ensure submission requirements and timelines are met
- Manage document receipt, translation, technical build and submission processes
- Ensure all submissions comply with regulatory guidelines and internal standards
- Maintain accurate documentation and ensure proper archival of all submission materials
- Identify and support process improvements across submission activities
- Provide guidance and support to colleagues where required and contribute to knowledge sharing
- Manage risks and elevate issues that may impact submission delivery
About You
- Proven experience working in a regulatory affairs or highly regulated environment
- Strong project management and coordination skills
- Excellent attention to detail and organisational ability
- Experience with electronic submissions and regulatory documentation
- Good understanding of regulatory guidelines and dossier requirementsStrong communication skills with the ability to work across global teams
- Degree in Life Sciences, Pharmacy, Business, IT or equivalent experience
- Ability to manage multiple projects and meet tight deadlines
The Opportunity
This is an exciting opportunity to join a collaborative, global team where you will play a key role in supporting the delivery of critical regulatory submissions and driving operational excellence.
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