Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin.
Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.
The role & Responsibilities:
To take lead role and responsibility for the effective planning, execution, tracking and reporting of assigned operational registration and life-cycle management projects for company Products. Promote high quality regulatory best practices, strategy definition, process efficiencies, effective communication, status reporting, planning and delivery of GRA and Corporate projects. Positive approach and attitude in a global multi-stakeholder company to help deliver high quality and timely registrations, local and global team build and support corporate growth and patient treatment options. Line Management of more junior team member (internal and external).
1. Acts as responsible Manager in the Regulatory Team member for assigned regulatory projects. Effectively plans, manages, and delivers assigned project workload. Preparation and responsibility for regulatory submissions including Marketing Authorization Transfer, CMC variation filling, initial MAA filling, labelling updates, renewals, publishing, CMC authoring and/or updates as required in line with corporate needs and timelines. Effective high-quality communication with Regulatory Authorities and internal BH functions (CMC, Quality, PV, Legal, Supply Chain, Commercial, Medical, Clinical, QA) and local offices. Effective high-quality communication with external partners on ad hoc basis.
Qualifications & Experience:
Pharmacy or Scientific Primary and/or advanced Degree(s). >5 years human pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions). Writing and preparation of relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling Experts. Experience of EU DCP and MRP MAAs. Project management experience. Excellent communication skills.
For full details please email your CV to tdunne@thornshaw.com or call Tina at +353 1 2784701
Thornshaw Scientific is a leading life sciences agency and part of the CPL Group of companies.
www.thornshaw.com
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