Regulatory Affairs Manager 16 Month Ftc

Reference Number: JO-2401-528544
Regulatory Affairs Manager 16 Month FTC
Rate: Negotiable
Job Type: Contract
Location: Hatfield

Regulatory Affairs Manager – 16 Month Maternity Cover FTC

Offering up to £70,000 Per Annum, plus benefits package

Flexible working Hertfordshire office

Our client, a leader in marketing branded and generic formulations is looking for an experienced Regulatory Affairs Manager to join their established team on a 16 Month maternity cover FTC. Working closely with the Regulatory Affairs Director you will be responsible for regulatory processes for EU and UK products including national phase of DCP and MRP. This would also include following MA approvals to ensure product maintenance . Currently operating a hybrid working policy, this opportunity will be based 3 days per week from their Hertfordshire offices. With the current incumbent due on maternity in July/August, the preference is to have an individual on board by June.

Job Responsibilities include;

– Act as Regulatory expert to define and implement strategies for submission of registration dossiers for medicines and Consumer Healthcare Products in EU and UK

– Preparation and submission of registration dossiers and post-registration changes

– Ensure EU and UK product labelling approval and compliance of the MA approval activities

– Building and maintaining close contacts and strong relationships with relevant authorities in EU and UK. Working with authorities through direct meetings, correspondence or teleconferencing as needed.

Candidate Requirements include;

– Must be eligible to live and work in the United Kingdom

– Life Sciences degree of the equivalent

– Preference for 5-6 years Regulatory experience within a pharmaceutical or generic business

– Previous experience with defining regulatory strategy for pre approval activities with EU affiliates

If this position is of interest to yourself please forward your CV to sophie.malyon@cpl.com.