ProClinical is currently working with a client, a leading US Biotech located in the South East that has a brand-new position available within their Global Markets team. You must have 5+ years of Regulatory Affairs experience working within global markets and must be able to thrive in a fast-paced, dynamic environment.
Skills and Requirements:
- Life Science degree
- Excellent communication skills both in writing and verbally
- A proven ability to co-ordinate the preparation of a variety of complex regulatory documentation in collaboration with other function
- Excellent organizational skills and ability to work on a number of projects with tight timelines, under minimal supervision.
- Preparation of MAA submissions
- Maintenance (variations / renewals etc) of Product Licenses in ROW markets
- Sound understanding of regulatory requirements, including ICH requirements and regional requirements and developing an appreciation of current global and regional trends in Regulatory Affairs
- Liaises directly with local Affiliates, distributors or agents to define/clarify submission requirements
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 Nicholas Walker on +44 207 4400 678 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.