Regulatory Affairs Manager
A leading pharmaceutical company is advertising a vacancy for a Regulatory Affairs Manager for their European office. This is an exciting opportunity to provide regulatory experience and skills and work with a prestigious establishment and significantly bolster a career in the life sciences field.
- Preparing and compiling the registration dossiers for national/DCP/MRP applications.
- Monitoring the registration process (national/DCP/MRP/CP procedures).
- Renewing and variating procedures for national and European procedures.
- Preparing/verifying variations documentation and notifications.
- Preparing SPCs, PILs, and labelling in accordance with QRD templates.
- Approving artworks for medicinal products in compliance with terms of registration dossier and pharmaceutical law requirements
- Solving the issues related to Community and national procedures for the registration of medicinal products.
- Assisting the QA department for preparation of pre GMP inspection activities.
- Assisting the PV department for preparation of pre Pharmacovigilance inspection activities.
- Preparing and maintaining MAs, variation, filing, product marketing status.
Skills and Requirements:
- 5-10 years Pharmaceutical Industry experience.
- Ideally, a history in pre and post-marketing authorisation of a product lifecycle.
- A strong understanding in product lifecycle management of generic drugs.
- Strong project management skills in regulatory operations.
- Experience in setting up and maintaining regulatory dossiers for the EU regions.
- Hands on experience for Applications of European COPP for IE/UK/NL/EMEA.
- Having experience on application for exemption from Sunset clause.
- Demonstrable project management skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 Keri Marshall at or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.