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Details

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.

Responsibilities
• 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.

Requirements
• 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