Regulatory Affairs Assistant Manager

Reference Number: JO-#####-528543
Regulatory Affairs Assistant Manager
Rate: Negotiable
Job Type: Permanent
Location: Hatfield
Regulatory Affairs Assistant Manager
Offering up to £60,000 Per Annum, plus benefits package
Flexible working Hertfordshire office
Our client, a multinational pharmaceutical business in generic manufacturing leader is looking for an Regulatory Affairs Assistant Manager to join their established team. Working under the direction of the Regulatory Senior Managers and Regulatory Director you will be responsible for generating regulatory submissions to target markets throughout Europe, delivering successful MA approvals. 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;
– Maintenance of the MA approval activities including preparation and submission of variations and preparation for product launch.
– Ensure EU and UK product labelling approval and compliance of the MA approval activities.
– Successfully interacting with global teams
– Timely generation and submission of regulatory applications (generally DCP, MRP,CP or national submissions) including responses to requests for further information from Competent Authorities, managing the national phase for MA issue following closure of the European Regulatory Procedures.
– Post-approval activities including maintenance of approved Mas (variation, Renewal & PSURs) and launch activities.
Candidate Requirements include;
– Must be eligible to live and work in the United Kingdom
– Life Sciences degree of the equivalent
– Preference for 4-5 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 #####.
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