Regulatory Affairs Manager - CMC 12 month contract
- Employer
- Barrington James
- Location
- Remote Working
- Salary
- Competitive rate
- Start date
- 18 Jul 2019
- Closing date
- 17 Aug 2019
View more
- Discipline
- Regulatory Affairs, CMC
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Management
Job Details
The opportunity to work with a leading Life Sciences Consultancy who works with 19 out of 25 of the top Life Sciences companies has become available! My Client is urgently seeking an experienced CMC Regulatory Affairs professional to work with them on a remote basis 5 days per week!
This role requires experienced professionals with strong CMC experience to work with them on Biologic products including monoclonal antibodies and insulin products.
Responsibilities include:
- CMC clinical (CTA/IND) and commercial filings through involvement at all steps of dossier authoring, review, approval:
-New applications for biological products including for monoclonal antibodies, insulin products
-License Maintenance of biological products: post authorization Changes, recurrent filings: annual reports, renewals
-Post-Marketing Commitments (PMCs) and Follow-up Measures (FUM)
- Develop global Regulatory CMC strategies for client’s biologics products to facilitate overall program goals
- Provide regulatory CMC expertise on cross-functional project teams working with suppliers and contract manufacturers
- Actively manage complex CMC regulatory submissions and ensuring quality and timelines are met for all pre and post approval biologics submissions
Suitable candidates will have:
- A graduate degree in Life Sciences
- Extensive experience in pre and post approval biologics CMC, including for monoclonal antibodies, insulin products regulatory filings
- Biosimilar experience would be an advantage
- Significant knowledge on Biologics regulatory requirements
- Significant knowledge of ICH guidelines and BLA submission requirements of various markets such as USFDA, EMA etc
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
Get job alerts
Create a job alert and receive personalised job recommendations straight to your inbox.
Create alert