Regulatory Affairs Advisor

Job Listing No: 9740000

Regulatory Affairs Advisor

Thornshaw Recruitment – Dublin – My client is a global enterprise with offices in Dublin. They currently have a new opportunity for a Regulatory Affairs Advisor to join the team. This is a permanent role. Key Responsibilities: Ensure local Regulatory compliance by: Submission of: – labelling changes based on the CCDS according to pharma SOPs – quality related changes according to the agreed timeliness – DSURs according to SOP and the local legislation – applications for new Marketing Authorisation, line extensions and new indications – renewals in order to keep Marketing Authorisations valid in the country- (if applicable) -educational materials, DHPCs and other risk minimisation activities according to SOP and HPRA guidelines – other documents and information as required Regular monitoring of the submission status with the authorities, contributing to the preparation of answers to deficiency letters and other Authority requests in cooperation with GRS/EPM, documenting all relevant contacts in a factu… – Permanent – Full-time

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