Our client, a pharmaceutical company which researches, develops and provides medicines that meet people’s health needs, are currently looking for a Regulatory Affairs Executive to join their team based on the South Coast of England. Reporting to the Scientific Affairs Manager, the main purpose of this Regulatory Affairs Executive role is to assist in the provision of support and expertise on Regulatory Affairs.
Further responsibilities of this Regulatory Affairs Executive role include:
- Ensuring compliance to all UK, Ireland and EU legislation regarding medical products.
- Facilitating the timely progress and success of all submissions relating to MAA.
- Providing expert advice on regulatory affairs to other departments within the organisation including the medical and marketing departments.
- Complying with all global and company SOPs.
- Ensuring that documents are filed appropriately, and update both the internal and external databases.
The successful candidate for this role will have experience of submitting variations, renewals, and PSURs to the MHRA and IMB. Further requirements of this Regulatory Affairs Executive role include:
- Excellent attention to detail.
- Excellent communication skills.
- Computer literate.
- Previous experience with influenza vaccines would be beneficial.
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