Job Description

Reference Number: JO-2307-518965
Principal Regulatory Affairs Officer/ Manager
Rate: Negotiable
Job Type: Permanent
Location: Hatfield

Principal Regulatory Affairs Officer/ Manager

Hertfordshire, UK \xe2\x80\x93 1 day per week in the office

Full-time \xe2\x80\x93 Permanent position

An exciting opportunity to join a leading pharmaceutical company that specializes in branded and generic products. The business works across multiple therapeutic areas including infectious diseases, oncology cardiovascular, CNS, and immunology.

In this position as a Principal Regulatory Affairs Officer/ Manager, you will be responsible for leading a number of projects in the UK and European markets including working on lifecycle maintenance activities and supporting junior team members.

Responsibilities

\xc2\xb7 Manage a number of new product registrations in the UK and EU and work closely with global colleagues to ensure compliance.

\xc2\xb7 Conduct lifecycle maintenance activities including new MAA, variations, renewals, and change of ownership applications.

\xc2\xb7 Compile/ author module 3 and any other CMC changes.

\xc2\xb7 Define UK/EU strategy and work cross-functionally with other departments to ensure products are reaching the correct markets.

\xc2\xb7 Support junior team members with training/ mentoring and potentially line manage junior professionals.

Requirements

\xc2\xb7 BSc or equivalent in Life Sciences or related area.

\xc2\xb7 At least 5 years plus of Regulatory Affairs experience with a focus on the EU market.

\xc2\xb7 Experience going through MRP and DCP for the UK or EU.

\xc2\xb7 Led a number of new MAA for the UK and EU markets.

\xc2\xb7 Must have the right to work in the UK.

This is an excellent opportunity to join a leading company that specialises in generics/ branded products. You will work in a lead position and will be responsible for multiple different products across the EU market. The role comes with a great basic salary, a 20% bonus, private healthcare, dental care, a pension scheme, and life assurance.

For more details please contact/ to apply for this position please send your update to date CV to

Clinical Professionals