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Regulatory Affairs Specialist Remote Working and Part Time Opportunity

Reference:AUMS-421161
Location: Dublin
Qualification:Degree
Experience:7-9 Years
Job Type:Part-Time
Salary:Not Disclosed
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Regulatory Affairs Specialist Remote Working and Part Time Opportunity
Our client are currently recruiting for a Regulatory Affairs Specialist to join their Dublin based team on a permanent basis. Remote working and part time hours are options for this role.

Responsibilities
• Coordinate and communicate critical input and critical timelines and deliverables to company leadership, development function and other key departments to facilitate regulatory submissions, including scientific advise, pre-submission, MA, Amendments, Annual reports, PSUR and post approval Supplements
• Communication of latest regulatory requirements to product development team
• Discussions with and guidance to company leadership and product development functions specific to pipeline products/projects as requested
• Perform detailed regulatory review and assessment of all documents, gather required data as needed to develop/finalize the documents, coordinate and prepare submissions
• Review technical reports, summary documents and change controls (chemistry, manufacturing and analytical controls) for appropriate content and justifications as well as for adherence to regulatory guidelines, strategies, and commitments.
• Manage, prepare, publish, using eCTD software, well-organized, scientifically sound submissions related to New Marketing Authorizations, Amendments, Annual reports, PSUR and Supplements that comply with applicable regulatory requirements in eCTD format
• Publish submissions on e-submissions platform
• Post-approval variations filing
• Regular interaction with various European regulatory agencies in preparation, pre-approval and post-approval management of products
• Communicate with project coordinators and others at European regulatory agencies (or regulators) including scientific advise, pre-submission, MA, post-approval communication

Requirements
• Degree in a scientific disciple such as Chemistry, Biology, Pharmacy or other health related field. Master’s degree preferred
• Experience: 7 + years in the Pharmaceutical Industry required
• Hands on experience in leading a variety of Regulatory submission activities (MAs, Post Approval Supplements, PSURs, Annual Reports.)
• Hands on experience in interacting with regulatory agencies. Experience of interaction with agencies in Germany or Netherlands a plus
• Hands on experience on working on eCTD software
• Ability to interpret Regulatory Authority policies and CMC guidance and correctly apply them as appropriate
• Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
• Familiar with a variety of pharmaceutical concepts, practices and procedures and the functioning of a regulatory affairs department
• Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks
• Detail oriented and highly organized
• Ability to persevere, collaborate and interact effectively with a variety of personnel including senior management


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

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




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