Description
Senir Regulatory AssociateA new role come up today with a leading Global Pharma who have a large presence in fighting against cancer, heart disease, diabetes, HIV/AIDS and psychiatric disorders.
If you are interested in the role or know anyone who might be please send your updated C.V to Natalie Hopkins directly to n.hopkins (a) realstaffing.com or call
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Senior Regulatory Associate
Salary: Up to £50,000 circa
Location: Berkshire area + flexibility around hours and 1 day a week home working.
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Description:
* Prepares and submits local regulatory documentation e.g variations, CTA's, substantial amendments etc to the MHRA and IMB.
* Assesses appropriateness of supplied global regulatory documentation for use in MHRA and IMB submissions.
* Liaises directly with the MHRA and IMB assessors for product related activities.
* Ensures local labeling is maintained in line with the Company Core Data Sheet.
* Reviews and approves all local packaging artwork.
* Participate in European Regulatory Team Meetings and assist with ensuring local requirements are considered in development strategy plans.
* Supports local projects and department related assignments and forums.
* Responsible for archiving of regulatory files and documentation and maintenance of regulatory databases.
Qualifications:
* Degree in Pharmacy or other relevant science degree, with experience in UK & Ireland regulatory affairs.
* Awareness of European regulatory legislation and processes.