Job Description
Regulatory Affairs Manager Opportunity 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.
Main Responsibilities
1. 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.
2. Promote high-quality regulatory best practices, strategy definition, process efficiencies, effective communication, status reporting, planning, and delivery of GRA and Corporate projects.
Key Accountabilities
* 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, 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 BH 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.
Qualifications and Experience
Pharmacy or Scientific Primary and/or advanced Degree(s). More than 5 years of 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.