Regulatory Affairs Associate
A six-month contract opportunity has arisen to join the International Regulatory Affairs team of a leading biopharmaceutical company based in Cambridge.
- In a European therapeutic group in International Regulatory Affairs and will be responsible for the preparation of regulatory submissions.
- Prepares non-clinical, clinical and safety regulatory documentation, as required, in accordance with Regulations, post-licensing commitments and legal obligations of the Marketing Authorisation Holder via the European Centralised Procedure, e.g. variations, renewals, responses to questions, Follow-up Measures, PSURs etc
- Responsible for ensuring product packaging and associated information is updated and maintained in accordance with Marketing Authorisations including the review and management of labelling translations and artwork.
- Prepares regulatory documentation to support Clinical Trial activities if required
- Participates in Regulatory team meetings, product team meetings and study management team meetings (for CTAs)
- Responsible for gaining and/or maintaining a broad knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to product teams.
Knowledge, Experience and Skills:
- Degree in biological/life sciences or pharmacy
- Relevant experience in Regulatory Affairs - post-approval regulation essential
- Experience representing Regulatory Affairs on cross-functional teams
- Experience working with the European Medicines Agency is preferred.
- Experience working with clinical trials in Europe is preferred
- Excellent oral and written English communication, organizational and teamwork skills
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 Numhom Sudsok on +44 203 8718 093 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.
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