Senior Regulatory Scientist

Job title : Senior Regulatory Scientist
Location : Surrey, England
Job type : Permanent
Salary : £45000 - £65000 per annum
Contact name : John Spring
Contact email : john.spring@secpharma.com
Senior Regulatory Scientist

This is a great opportunity to join a company of over 200 dedicated Regulatory Affairs experts offering consulting services to global clients across the life sciences sector including pharmaceuticals, biotechnology and medical devices. The position is a permanent role, offering a great career growth plan and exposure to multiple RA projects in various products including ATMPs, IVDs, and rare disease drug products.

Salary & Benefits:

Full details on request

Role and responsibilities:

* Define and implement regulatory strategies for development of biologic and drug products
* Ensure regulatory compliance with global guidelines
* Writing and reviewing of regulatory submissions including PIPs & PSPs (paediatrics) and ODDs (orphan drugs) as well as CTAs and INDs for ATMP products (cell therapies etc.)
* Manage MAAs in Europe and NDAs or BLAs (biologics) for the US market
* Manage variation application and extension processes
* Contribute to the growth of active projects, manage and take charge of new projects and meeting with prospective new clients to discuss collaborations
* Attend and present at regulatory conferences and write relevant articles

Requires skills and qualifications:

* An advanced and relevant scientific degree
* 3+ years' experience in Regulatory Affairs, with an emphasis on drug development
* Varied experience would be a plus, for example as a consultant or working in a CRO
* Excellent project management skills, communication and presentation
* Successful track record in regulatory healthcare authority interactions


The position will allow the successful applicant to grow their career in multiple ways - there is variation in the projects, the products and the stage in the clinical life cycle which means you will have great exposure to many different activities and create a very well rounded RA profile. Additionally, it is a leading organisation, one of the best in their field.


To apply for this position and put yourself under immediate consideration, send your CV to john.spring@secpharma.com or call +44 (0) 207 255 6650