Regulatory Affairs Specialist
- Regulatory Affairs
Regulatory Affairs Specialist- Permanent
Extremely Competitive salary and benefits package, possible relocation package too If required.
Job reference number- JO-1901-421772
A very exciting opportunity for a Regulatory Affairs Specialist has come up, to join a leading and extremely reputable Global Pharmaceutical company with a huge dominance within Life Sciences.
Coming from a strong Regulatory background, you will be expected to:
-Be the Regulatory lead for new product registrations in the EU
-Have full responsibility for preparing and maintaining dossier documentation, CMC documentation, variations and product information.
-Take full ownership of Life-Cycle management of products in the EU and the core dossier maintenance of globally launched products.
-Provide expert Regulatory advice and strategy advice to other core-functional teams within the business.
-Lead discussions with Competent Authorities and develop plans to achieve success.
-Manage and deliver complex regulatory projects, for problem solving and provide solutions to these.
As a successful applicant, you must have:
-At least 5 years experience in a Regulatory Affairs role, ideally with MAA experience.
-Experience in Post-approval submissions working with DRP/DCP and EU national procedures.
-Extensive knowledge of EU legislation.
-Experience dealing with EU Competent Authorities.
-The ability to prepare, review and maintain CMC documentation.
-Experience developing and implement Regulatory Strategies.
If this role is of interest to you, and you would like to learn more then I am contactable on 01189522797 where I would be more than happy to discuss the role further.
Alternatively, feel free to email me your CV to firstname.lastname@example.org for immediate consideration.
If this role is not quite right, no worries at all. If youre interested in hearing about other great career opportunities, then please still get in touch as there are numerous Regulatory requirements at the moment. Additionally, if you know someone that may be interested in this role then we reward 250 worth of vouchers for every successful placement so please let me know!