Regulatory Affairs Assistant Manager

1 month ago

London, United Kingdom Clinical Professionals Limited Full time

Regulatory Affairs Manager/ Assistant Manager
Job Type: Permanent
Job Title: Regulatory Affairs Manager/ Assistant Manager
North London, UK – Hybrid
Permanent
Attractive salary and package
Regulatory Affairs Manager/assistant Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a personable and detail-oriented professional to join the small team and lead a number of RA activities for an established generics portfolio.
In this role, you will be responsible for managing regulatory submissions, driving regulatory strategy, new registrations, and variations applications for a range of different generic products marketed in the European market.
Manage required regulatory processes for European products including submitting submissions through National MRP and DCP.
· Drive/support European regulatory strategies and work closely with local and GRL to ensure all strategies are in line.
· Get involved in pre-approval activities, including initial MAA, scientific advice, and working as an EU strategist for a broad portfolio.
· Ensure EU product labelling approval and compliance with the MA approval activities.
· Bachelor’s degree or higher in Life Sciences or technical field.
· 4 to 8 years of relevant regulatory experience especially within the European market.
· A strong communicator who is able to navigate through difficult conversations with senior stakeholders.
· The role will play a pivotal part in the Regulatory Affairs team and ensure all compliance. The role includes some excellent benefits including a generous bonus scheme.

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