Description
Job Role: Regulatory Affairs ExecutiveSalary: Competitive + Incentives
Location: North West UK
About the role:
- Coordinating and submitting new marketing authorisation applications via the DCP, MRP, and National procedure
- Coordinating and submitting post approval changes including variations, renewals etc. and to provide assistance in the development of variation submission strategies
- Submission of changes to the PIQu and other artwork changes
- Reviewing, writing and advising on SmPCs and artworks
- To be part of a team and assist in documentation / archiving / communication to multiple departments
- Update and maintenance of electronic document management systems
- Complying with SOPs and assisting in their development and review
- Monitoring legislation and professional publications
- Negotiating with regulatory authorities to achieve most favourable conditions for marketing authorisations or variations
- Representing Regulatory Affairs at internal and external meetings
Job Requirements:
- A degree (or equivalent), preferably in life sciences or in a pharmaceutical related subject
- Relevant experience of working in the regulatory arena and a sound knowledge of European procedures is essential
- Experience in UK/IE and EU applications and submissions
- An exceptional eye for detail required
- Excellent verbal and written communication skills
- A high degree of comfort working with electronic systems
- The ability to organise own workload with minimum supervision
- The ability to present the Company's interests in a professional and authoritative manner and to conduct negotiations with regulatory bodies
My client is looking for an individual who has the potential skills to deliver in a role they are looking to fill. They are searching for crucial talent just like us here at Real. The rapid growth of this company means that an ability and willingness to put your hands to most things in the regulatory field is a criterion. This is an excellent opportunity to gain a broad experience in all aspects of regulatory affairs and start your career progression.
For more information please send your C.V to Latifah Khan at l.khan(a)realstaffing.com or call me on the following number: for more information.