Regulatory Affairs Manager - NEW OPPORTUNITY
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We are seeking a skilled Regulatory Affairs Manager to join our team in Dublin. The successful candidate will be responsible for the effective planning, execution, tracking, and reporting of assigned operational registration and life-cycle management projects for our products.
Key Responsibilities:
* 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 members (internal and external).
* 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 filing, initial MAA filing, 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 business functions (CMC, Quality, PV, Legal, Supply Chain, Commercial, Medical, Clinical, QA) and local offices.
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 (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.
Our ideal candidate is a motivated and organized individual who can work effectively in a fast-paced environment and possess excellent communication skills. If you are a highly skilled Regulatory Affairs Manager looking for a challenging opportunity, please submit your application.