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Senior CMC Reg Affairs Specialist

Reference:AVDP-724052 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Senior CMC Reg Affairs Specialist
Our client is an organisation with a focus on the development and manufacture of generic pharmaceutical products. They are currently recruiting for a Senior CMC Reg Affairs Specialist to join their team based in Dublin. The successful candidate will report directly to the Head of Regulatory Affairs. The role will include some travel.

• Critical review of high quality, Chemistry Manufacturing and Control (CMC) detailed regulatory documents and identify any possible deficiencies prior to dossier submission to EU and US Agencies
• Liaise and work closely with other company personnel such as R&D, Medical Affairs, Quality, Business Development and Licensing to ensure accuracy of such documents
• Prepare and submit MAAs (e.g. generic/bibliographical) in the EU via national, MRP, DCP routes and ANDAs and NDAs (mainly 505(b)(2)) projects) in the US in conformance with applicable regulatory guidelines
• Provide regulatory support for out-licensing activities in EU, US and international territories
• Liaise with Regulatory Authorities and Affiliates
• Mentor, train and daily oversight of Regulatory Affairs Assistants and Officers within the regulatory department
• Manage post-licensing activities (variations, renewals, PSURs, Amendments, Supplements, Annual Reports etc.)
• Assist the Head of Regulatory Affairs on complex regulatory strategy issues and help develop solutions with members of the regulatory department and other internal stakeholders.

• Relevant life science or pharmacy degree
• 7-10 years relevant EU and ideally US regulatory affairs experience in the pharmaceutical industry
• Previous exposure to formulation development, CMC and CTD Dossiers for MAA is essential
• Working knowledge of eCTD is an advantage but not essential
• Ability to create good relations on an interpersonal level with a variety of people at different levels within any given organisation
• Excellent communicator and negotiator
• Ability to travel

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252