Regulatory Affairs Senior Manager – 12 month contract
- Employer
- Barrington James
- Location
- Near London
- Salary
- Competitive rate
- Start date
- 16 Aug 2019
- Closing date
- 15 Sep 2019
View more
- Discipline
- Regulatory Affairs, CMC, Compliance, Labelling, Regulatory Writing
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Senior Management
Job Details
A leadership position at one the leading biotechnology companies, who placed within the Top 10 Most Innovative Companies in Biotech for 2019, has become available. My Client is searching for a Regulatory Affairs professional to work with them on a freelance contract for the next 12 months.
The Regulatory Affairs Senior Manager will report into the Regional Group Leader, assisting them with executing their approved strategy and representing the region.
Key responsibilities include, but are not limited to:
- Advising the Global Regulatory Team (GRT) on regional considerations in developing strategy
- Implementing regional needs with relevant stakeholders
- Planning and managing regulatory submissions, including clinical trial and marketing applications
- Managing regional label negotiation activities and directing the development of the product label with the LWG
- Ensuring regulatory compliance for product
- Providing managerial leadership and direction to assigned team
Candidates are required to match the following:
- 10 years regulatory affairs experience
- Experience in providing scientific advice
- Strategic management experience
- Experience with EU legislation and guidelines
Desired experience:
- Paediatric Investigation Plans
- Orphan Drug applications
- Early product development
- Clinical Safety Labelling
- Variations
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
Company
We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.
Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.
- Website
- https://barringtonjames.com/
- Telephone
- 01293 776644
- Location
-
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB
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