Regulatory Affairs Specialist
This is a full-time/hybrid position reporting to the Global Regulatory Affairs Associate Director.
The role involves leading 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.
Responsibilities include:
* Acting as a responsible manager in the Regulatory Team member for assigned regulatory projects;
* Effectively planning, managing, and delivering assigned project workload;
* Preparing and being responsible for regulatory submissions including Marketing Authorization Transfer, CMC variation filling, initial MAA filling, 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;
* Effective high-quality communication with external partners on an ad-hoc basis.
Qualifications and Experience:
A pharmacy or scientific primary degree, advanced Degree(s), and/or equivalent experience. More than five years of human pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets, such as variations, renewals, new Marketing Authorisation Applications (MAAs) submissions.
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.
We are seeking a highly skilled and experienced professional to join our team. The ideal candidate will have a strong background in regulatory affairs, excellent communication skills, and the ability to work effectively in a global multi-stakeholder environment.
Please submit your CV for consideration.