Regulatory Affairs Manager Opportunity
We are seeking a highly skilled Regulatory Affairs Manager to join our team in Dublin.
This is a full-time/hybrid position, reporting to the Global Regulatory Affairs Associate Director.
Role and Responsibilities:
The successful candidate will take a lead role and responsibility for planning, executing, tracking, and reporting assigned operational registration and life-cycle management projects for our company's products.
They will promote high-quality regulatory best practices, define strategies, improve process efficiencies, communicate effectively, report on status, plan, and deliver GRA and Corporate projects. A positive attitude and approach in a global multi-stakeholder environment will be key to delivering high-quality and timely registrations, building local and global teams, and supporting corporate growth and patient treatment options.
* Act as a responsible manager in the Regulatory Team member for assigned regulatory projects, effectively managing and delivering assigned project workload.
* Prepare and be responsible for regulatory submissions, including Marketing Authorization Transfer, CMC variation filings, initial MAA filings, labelling updates, renewals, publishing, CMC authoring, and updates as required in line with corporate needs and timelines.
* Communicate effectively with Regulatory Authorities and internal functions (CMC, Quality, PV, Legal, Supply Chain, Commercial, Medical, Clinical, QA) and local offices.
* Communicate with external partners on an ad-hoc basis.
Qualifications and Experience:
A pharmacy or scientific primary degree, or an advanced degree in a related field.
Experience with writing and preparing 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.