ProClinical is seeking a Regulatory Affairs consultant and technical expert who will support the preparation and submission of global regulatory documents for biopharmaceutical products within a life science consulting company. This role will be based in France, on a contract basis.
- Provide regulatory guidance and act as technical expert to support product development teams in relation to strategic planning, pre-marketing, and related submissions to support product launch
- Support new and existing regulatory applications across international regions by defining relevant regulatory data required
- Guides compliance with relevant regulations in product development, support of claims, content labelling, and promotional materials.
- Responsible for Regulatory Affairs support during internal and external audits.
- Represents Regulatory Affairs on cross-functional project teams.
Skills and Requirements:
- Minimum 4 years' experience in Regulatory Affairs
- Degree in relevant subject (MSc, BSc, Pharmacy, Biochemistry, etc …)
- Strong communication abilities in English, ability to speak another EU language is a bonus e.g. German, French
- Strong Knowledge MS Office (Word, Excel, Outlook)
- Strong knowledge of regulatory requirements and guidelines for biopharmaceutical products
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 Amie Touray on +44 203 814 1317 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.