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
