Overview

Reference Number: JO-2202-486486
Regulatory Affairs Manager
Rate: Negotiable
Job Type: Permanent
Location: Hemel Hempstead

Regulatory Affairs Manager

Location: Hemel Hempstead (Office based)

Salary:50,000 – 75,000

Regulatory Affairs Manager position working for a pioneering niche pharmaceutical company currently undergoing rapid expansion. Working on one of the worlds leading multi-million-pound IVF products.

The company places great emphasis on developing staff & strongly believes in an open, empowered friendly team culture.

As a regulatory affairs manager you will be planning, preparation and submission of MA applications in North America, Russia, and Australia/New Zealand and addressing RFI/RTQ Response, post-approval variations, renewals, post-marketing commitment.

Responsibilities

– Reviewing and submitting artwork and labelling changes, including management of third-party artwork house.

– Support of maintaining MAs in the EU, MENA, Africa, Asia and the UK which involves liaising with CMOs and third-party service providers for required documents on regular basis.

– Responsibility for ensuring that all relevant electronic systems are updated and maintained in alignment with regulatory submissions and commitments.

Essential Requirements

– Bachelors degree equivalent or higher qualification within life science.

– Knowledge of EU DCP/National and lifecycle maintenance.

– Authoring & preparation of regulatory packages and documents for submissions.

– Submission experience within EU and/or RoW markets

The role also comes with an excellent benefits package including; 31 days holiday, health insurance, company mobile, and laptop, and a contributory pension scheme.

If you are interested in this role or would like more details please email your CV to chris.bart@cpl.com