Reference Number: JO-1911-440197
Regulatory Affairs Assistant Manager
Job Type: Contract
Regulatory Affairs Associate Manager
12 Month FTC (Maternity Leave)
Regulatory Professionals is collaborating with a leading generic pharmaceutical firm who are looking for a Regulatory Affairs Assistant Manager on a 12 Month Fixed Term Contract based in Watford. Working directly with the Regulatory Affairs Manager and will be responsible for maintaining the validity of the existing Marketing Authorisation Applications within the EU. The ideal candidate will have good availability to start preference before the Christmas break and will have prior experience within Regulatory Affairs preferably having worked on decentralised procedure and mutual recognition procedure.
Job Responsibilities include;
Successfully interact with the project and functional teams in India to ensure that data generated is appropriate and will be presented and compiled in accordance with EU requirements
Oversight of the Regulatory Tracking Database. Liaise with contract services provider to ensure that the Regulatory Tracking Database is able to provide relevant and timely information on pending and approved products
Manage the submission process (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 and launch activities
Candidate Responsibilities include;
Life Sciences degree or the equivalent
Preference for a minimum of 4 years regulatory experience, ideally in a generic environment
Experience of decentralized procedure and mutual recognition procedure is required (essential).
Some centralized procedure experience would be an advantage.
Submissions of eCTD procedure submissions would be an advantage.
If this position is of interest to yourself please call Sophie at Regulatory Professionals on 0118 952 2797 or alternatively send your CV to firstname.lastname@example.org.