Job Reference: J5631683
Updated On: 12/06/2019
Status: Now Interviewing
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Role OverviewAn exciting opportunity as a Regulatory Affairs Assistant has opened within a leading Generics Pharmaceutical company based near Heathrow. As the Regulatory Affairs Assistant you will be responsible for supporting the Regulatory Affairs team with Post-Marketing activities including variations and renewals.
This position would suit a recent graduate with exposure to Regulatory Affairs or someone currently in a Regulatory Affairs team who is looking to expand their career beyond Admin duties.
Key Duties and ResponsibilitiesYour duties as the Regulatory Affairs Assistant will be varied however the key duties and responsibilities are as follows:
1. Publishing and Tracking of UK and EU regulatory submissions.
2. Supporting Variation submissions including Type 1a, 1b and Type 2 as well as updating of old national licences.
3. Assisting the Quality Assurance department in maintaining the QMS and various tasks and procedures (OOS, change controls, deviations, CAPAs etc).
4. Maintain the regulatory database and assist in cross functional meetings.
Role RequirementsTo be successful in your application to this exciting opportunity as the Regulatory Affairs Assistant we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (Pharmacology, Chemistry, Pharmacy etc.). Experience in a Regulatory Affairs team will be beneficial to your application.
2. Knowledge of Regulations followed by Pharmaceutical companies would be a benefit. A passion for Regulatory Affairs is vital.
3. Ability to priorities and organise workload as well as strong team-working and communication skills.
Key Words: Regulatory Affairs | Entry Level | Graduate | Administration | Variations | Renewals | Regulatory Support | UK | EU | Submissions | Organisation | Communication
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