Regulatory Affairs Executive/Officer

Regulatory Affairs Executive/Officer

North London, UK – Hybrid (3 days in the office)

Regulatory Affairs Executive/Officer 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 team and support several Regulatory Affairs activities.

The role will be focused on lifecycle management and post-approval activities for established generics products in the UK, Ireland, and EU markets. The right individual will be detailed-driven and be confident in communicating with stakeholders at all levels.

Responsibilities

• Take responsibility for post-approval activities including, variations (type 1a, 1b, and type 2), renewals, license changes, labelling and CMC change controls.
• Supporting the preparation of new MAA in the UK and Europe and supporting any new registration applications.
• Supporting labelling and artwork changes (SmPc, PIL, and mock-ups)
• Preparation, submission, and management of approvals of National, MRP, and DCP, applications in the UK and European region.

Requirements

• Bachelor’s degree or higher in Life Sciences or technical field.
• 18 months to 2 years of relevant regulatory experience.
• Full Right to Work in the UK.
• A strong communicator who can navigate through difficult conversations with senior stakeholders.
• Previous experience working on generic submissions, medical device experience is not relevant.

This position allows for great career progression opportunities as well as the chance for the right individual to establish themselves within a leading generics organisation. This role will play a pivotal role in ensuring regulatory compliance and ensuring deadlines are met on time.  

To apply for this role you MUST have the full right to work in the UK as this employer does not provide sponsorship. This role also requires someone to be in the office 3x a week and you will need to be located within a commutable distance.

For more details please email your CV to