Regulatory Affairs Product Specialist

Our client, a global biotechnology company that employs over 20,000 people across the world, is looking to hire a Regulatory Affairs Product Specialist. The company specialise in creating breakthrough therapies for rare diseases and works to produce an innovative pipeline across their key therapy areas.

The NSI Coordinator will act as International RA contact point for the cross functional team on the Network Strategy Implementation work stream, including but not limited to, site-to-site technical transfers, QC transfers, changes to external network, and internalization.
This will include formulating and implementing regulatory submission strategy covering the International regions (APAC, LATAM, EAMEA, Japan and China) and drive the completion of variation package including Mod 1 by working with various cross functional stakeholders.

Job Responsibilities:

• Serve as the International RA contact point on the Network Strategy Implementation work stream
• Serve as a liaison between GRA, R&D and International LoC
• Provide International RA expertise to the cross-functional teams
• Help complete change control assessments by working with the change owner and impacted regions
• Maintain regulatory intelligence tracker o Monitor and track the progress of variation submission and approval.

Skills and Requirements:

• The candidate will need good experience of Regulatory CMC work and be able to lead initiatives.
• The role will initially be offered as an 11-month contract but the project is expected to last for 3 years so will most likely be extended.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.