Regulatory Affairs Manager Job Opportunity at a Global Pharmaceutical Company in Dublin
About the Role
We are seeking a highly experienced Regulatory Affairs Manager to join our team in Dublin. Reporting to the Global Regulatory Affairs Associate Director, this is a full-time/hybrid position.
Key Responsibilities:
* Lead and manage assigned operational registration and life-cycle management projects for company Products, ensuring effective planning, execution, tracking, and reporting.
* Promote high-quality regulatory best practices, strategy definition, process efficiencies, effective communication, status reporting, planning, and delivery of GRA and Corporate projects.
* Maintain a positive approach and attitude in a global multi-stakeholder environment to deliver high-quality and timely registrations.
* Support corporate growth and patient treatment options by managing regulatory submissions, including Marketing Authorization Transfer, CMC variation filing, initial MAA filing, labelling updates, renewals, publishing, CMC authoring, and/or updates as required.
* Act as responsible Manager in the Regulatory Team member for assigned regulatory projects, effectively planning, managing, and delivering assigned project workload.
* Communicate effectively with Regulatory Authorities, internal functions (CMC, Quality, PV, Legal, Supply Chain, Commercial, Medical, Clinical, QA), and local offices, as well as external partners on an ad hoc basis.
Requirements
* 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.
* 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.
About Us
Thornshaw Scientific is a leading life sciences agency and part of the CPL Group of companies.