Senior Manager - Regulatory Affairs

Job title : Senior Manager - Regulatory Affairs
Location :
Job type : Permanent
Salary : Negotiable
Contact name : John Spring
Contact number : +44 (0) 207 255 6650
Contact email :
(Senior) Manager - Regulatory Affairs

This is a unique opportunity to work with a leading Biotechnology company who are the front runners in the fight against rare diseases in the neurology field. The company are extremely well situated financially and have a very exciting pipeline of cell and gene therapy products to add to their market leading existing portfolio. This role will offer the successful applicant the chance to work at the forefront of medicine, transforming lives on a global scale.

Salary & Benefits:

Excellent salary and benefits package, full details available on request

Role and responsibilities:

*Provide operational and strategic regulatory direction, supporting the global program regulatory team through activities in development, registration and approval/post-approval activity
*Implement strategy and operational activity on a global scale including; contributing to regulatory functional plans globally, implementing regulatory inspection readiness and management of sub-teams
*Interaction with Healthcare Authorities; set objectives HA interactions, preparing briefing documentation, leading rehearsal meetings and develop plans for timely response to HA requests
*Oversight of submissions and approvals; reviewing global dossiers, avoiding clock stops, reviewing approving and submitting CTAs and INDs and submitting risk management plans

Requires skills and qualifications:

*Minimum 5 years' experience (at least 8-10 for the Senior Manager) within Regulatory Affairs roles in the biotechnology/pharmaceutical field
*Excellent working knowledge of regulatory submissions and approvals in major regions (the more the better)
*Strong experience in Healthcare Authority interaction and negotiation
*Involvement in RA and biologics or drug development across phases 1-4 in regulatory strategy, post-marketing, dossier submission and commercialisation
*Previous work in ATMPs (cell therapy, gene therapy etc.) strongly preferred
*Rare and Orphan Disease experience strongly recommended
*Entrepreneurial, dynamic and curious attitude, constantly looking to drive improvements

Nobody else offers the products that this company can - they truly are the world leaders in their field and this opportunity gives you the chance to grow with them and make a significant difference to the lives of thousands of patients across the world.

To apply for this position and put yourself under immediate consideration, send your CV to or call +44 (0) 207 255 6600