Regulatory Affairs Manager
This is an excellent opportunity to work for a global leader in the life sciences industry. The company is currently looking for a Regulatory Affairs manager to join their dynamic team in Cambridge.
- Advising the GRT (Global Regulatory Team) on regional considerations in developing strategy
- Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
- May manage one or more regional leads or support roles
- Act as a contact with relevant regulatory agencies in fulfilling local obligations by product assignment
- Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant sr. management
- Review and approve promotional and non-promotional materials for use in the region
- Manage the product lifecycle for individual countries per national agency requirements
- Provides content guidance for regional regulatory documents and meetings in accordance with GRT strategy
- Manages in the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
- Supports regional label negotiation activities
- Knowledge of relevant legislation and regulations relating to medicinal products
- Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals.
- Knowledge of drug development Cultural awareness and sensitivity to achieve results across both regional country and International borders.
Skills and Requirements
- 4-6 years of work experience, preferably but not limited to regulatory affairs
- Bachelor diploma
- Excellent written and verbal communication skills in English
- Creative and good computer skills: Outlook, Power Point, One Note, Excel,
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 contact Peter Duvall on 44 203 0789 542 or upload your CV on our website - www.proclinical.com/send-cv
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