Overview

Reference Number: JO-2402-530211
Regulatory Affairs Manager/ Assistant Manager
Rate: Negotiable
Job Type: Permanent
Location: North London

Job Title: Regulatory Affairs Manager/ Assistant Manager

Location: North London, UK – Hybrid

Employment type: Permanent

Remuneration: 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.

Responsibilities

·       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.

·       Manage a large portfolio of European licenses and be responsible for ensuring maintenance, renewals, variations changes are all done in due time.

·       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.

·       Successfully interact with the EMA and respond to health authority questions.  

Requirements

·       Bachelor’s degree or higher in Life Sciences or technical field.

·       4 to 8 years of relevant regulatory experience especially within the European market.

·       Previous experience submitting through MRP, DCP and national procedures.

·       Ideally previous experience working on pre-approval and driving a large portfolio.  

·       A strong communicator who is able to navigate through difficult conversations with senior stakeholders.

·       Good team working skills, able to influence to achieve objectives.

 

This position allows for the right candidate to work for a leading generics manufacturer and take charge of European submissions. 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.

To apply for this role you must have the full right to work in the UK as this employer does not provide sponsorship. For more information please contact lucy.kirkaldy@cpl.com

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