Regulatory Affairs Manager
We are seeking a highly skilled 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:
* Taking the lead role and responsibility for planning, executing, tracking, and reporting on operational registration and life-cycle management projects for company products.
* Promoting high-quality regulatory best practices, strategy definition, process efficiencies, effective communication, status reporting, planning, and delivery of GRA and Corporate projects.
* Maintaining a positive approach and attitude in a global multi-stakeholder environment to help deliver high-quality and timely registrations.
* Supporting corporate growth and patient treatment options.
* Line management of more junior team members (internal and external).
* Acting as responsible manager in the Regulatory Team member for assigned regulatory projects.
* Effectively planning, managing, and delivering assigned project workload.
* Preparation and responsibility for regulatory submissions including Marketing Authorization Transfer, CMC variation filing, initial MAA filing, labeling 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.
* Effective high-quality communication with external partners on an ad hoc basis.
Requirements:
* A 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 Authorization 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.