Regulatory Affairs Specialist: Leading the Way in Pharmaceutical Registration
This is a full-time/hybrid position that reports to the Global Regulatory Affairs Associate Director.
The successful candidate will be responsible for planning, executing, tracking, and reporting on assigned operational registration and life-cycle management projects for company products. They will promote high-quality regulatory best practices, strategy definition, process efficiencies, effective communication, status reporting, planning, and delivery of GRA and corporate projects. A positive approach and attitude are essential in this role to help deliver high-quality and timely registrations, support local and global team growth, and contribute to patient treatment options.
* Acts as a responsible Manager in the Regulatory Team member for assigned regulatory projects.
* Effectively plans, manages, and delivers assigned project workload.
* Prepares and is responsible for regulatory submissions, including Marketing Authorization Transfer, CMC variation filing, initial MAA filing, labelling updates, renewals, publishing, CMC authoring, and updates as required in line with corporate needs and timelines.
* Maintains effective high-quality communication with Regulatory Authorities and internal departments (CMC, Quality, PV, Legal, Supply Chain, Commercial, Medical, Clinical, QA) and local offices.
* Maintains effective high-quality communication with 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 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.