|Location: Manchester, Greater Manchester||Salary: £35000 - £40000 per annum|
|Type: Temporary||Contact: Daniel Paine|
Senior Regulatory Affairs Officer / Executive
I am working with a leading development and manufacturing organisation in the pharmaceutical industry based near Manchester that are actively looking for a Senior Regulatory Affairs Officer / Executive to join their team.
The Senior Regulatory Affairs Officer / Executive will have the following responsibilities:
- Maintain the marketing authorisations
- Prepare the variations and new marketing authorisation applications in the UK and Europe in eCTD format
- Compliance reviews of internal and external manufacturing documents, batch records, protocols, API quality control records, validation protocols, etc.
- Write and review standard operating procedures and instructions
- GAP analysis / MA review
The Senior Regulatory Affairs Officer / Executive must have the following requirements:
- Degree in Life Sciences, Pharmaceutical Sciences or equivalent;
- Min 6 years' experience in regulatory affairs
- Must have a strong regulatory background with knowledge of EU process and legislation
- Experience in eCTD and writing CMC CTD documents
- Great written and spoken English
My client is keen to get the right fit for their team; so, if you feel as though you have the skills, experience and desire to be an exceptional Senior Regulatory Affairs Officer / Executive; then this is the opportunity for you. Apply today!