Our client, a leading pharmaceutical company in the south East has a brand-new requirement in their team for a Regulatory Affairs professional who has demonstrable experience working within a global environment.
- Ensure suitable dossiers (marketing authorisation applications / post-approval submissions) are prepared and dispatched on-time for products in designated EU and non-EU territories.
- Ensure databases and systems are maintained in accordance with current SOPs to fulfil regulatory obligations.
- Work closely with internal and external parties, establishing effective communication channels and excellent working relationships to progress regulatory activities.
- Advise management of the status and progress of assigned projects identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects.
- Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities) and use this information to optimise departmental procedures and processes.
- Support Line Manager through participation in project teams; and mentoring/training junior team members
Skills and Requirements:
- BSc in Life sciences or related area.
- At least 24-months Regulatory Affairs experience.
- Proficiency in speaking, comprehending, reading and writing English.
- Excellent prioritization and time-management skills.
- IT literate with proficiency in using word, excel, power point.
- Previous experience of Document Management System useful.
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.