Regulatory Project Manager - 0.5 FTE 12 month contract

The opportunity to work with a vibrant, global Bio-pharmaceutical company has become available. Our Client is urgently seeking an experienced Regulatory Project Manager to work on a 50% FTE 12-month contract. They will be required to work onsite at their office in Switzerland, near Lausanne.   

Responsibilities include:

·         Supporting and reporting to the Global Regulatory CMC Lead

·         Coordinate collection of documents from site to ensure submission readiness

·         Support Regulatory CMC tracking and planning

·         Coordinate and follow up regulatory meetings

·         Assist in the coordination, collection and consolidation of source information to appropriately support the filing of submission documents or inspections (e.g addressing regulatory questions and Answers to Objections, authoring of IND/IMPD, new BLA/MAA, roll out in international countries)

·         Prepare updates for Technical and Strategic internal and Alliance Committees

Suitable candidates will have:

·         Minimum of 5 years’ experience

·         Degree in a Life Science or related discipline (minimum MSc or equivalent)

·         Proven ability to handle software needed to support the regulatory function

·         Excellent communication and presentation skills 

A full job description is available upon application.

I specialise in recruiting Regulatory Affairs professionals throughout Europe, if you would like to speak to me regarding one of my current vacancies, or simply be made aware of opportunities as they arise then please call me today on +44 (0)1293 77 66 44 for a confidential discussion.

Alternatively e-mail me on JASmith@barringtonjames.com.  

I look forward to hearing from you soon!

Jasmine Smith

Contract Consultant ~ Regulatory Affairs

+ 44 (0)1293 77 66 44