Regulatory Affairs Manager - NEW OPPORTUNITY New Regulatory Affairs Manager - NEW OPPORTUNITY New 1 day ago Be among the first 25 applicants
Job Description Form
Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin.
Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.
Job Description Form
Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin.
Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.
The Role & Responsibilities
To 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.
Promote high quality regulatory best practices, strategy definition, process efficiencies, effective communication, status reporting, planning and delivery of GRA and Corporate projects.
Positive approach and attitude in a global multi-stakeholder company to help deliver high quality and timely registrations, local and global team build and support corporate growth and patient treatment options.
Line Management of more junior team member (internal and external).
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 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 BH functions (CMC, Quality, PV, Legal, Supply Chain, Commercial, Medical, Clinical, QA) and local offices.
Effective high-quality communication with external partners on ad hoc basis
Qualifications & Experience
Pharmacy or Scientific Primary and /or advances 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 Authorisation 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.
For full details please email your CV to or call Tina at +353 1 2784701
Thornshaw Scientific is a leading life sciences agency and part of the CPL Group of companies.
Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Legal Industries IT Services and IT Consulting Referrals increase your chances of interviewing at Cpl Technology - Tech Recruitment Experts by 2x
Get notified about new Regulatory Affairs Manager jobs in Dublin, County Dublin, Ireland .
Dublin, County Dublin, Ireland 1 week ago
Global Regulatory Affairs Manager (Global Program Regulatory Manager) Dublin, County Dublin, Ireland 1 week ago
Clonee, County Meath, Ireland 2 weeks ago
Regulatory Affairs Manager - NEW OPPORTUNITY New Dublin, County Dublin, Ireland 13 hours ago
Regulatory Affairs Manager - NEW OPPORTUNITY Dublin, County Dublin, Ireland 17 hours ago
Clonee, County Meath, Ireland 2 weeks ago
Dublin 1, County Dublin, Ireland 23 hours ago
Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager) Dublin, County Dublin, Ireland 1 week ago
Dublin, County Dublin, Ireland 2 weeks ago
Dublin, County Dublin, Ireland 1 week ago
Dublin, County Dublin, Ireland 4 days ago
Dublin, County Dublin, Ireland 2 weeks ago
Dublin, County Dublin, Ireland 3 weeks ago
Dublin, County Dublin, Ireland 16 hours ago
Dublin, County Dublin, Ireland 6 days ago
Dublin, County Dublin, Ireland 2 weeks ago
Manager of Regulatory Reporting - Investment Bank Dublin, County Dublin, Ireland 2 weeks ago
Dublin, County Dublin, Ireland 4 days ago
FS Business Consulting - Finance & Risk Regulatory Reporting - Manager - Dublin Dublin 2, County Dublin, Ireland 2 weeks ago
FS Business Consulting - Finance Regulatory Reporting and Transformation - Manager - Dublin Dublin 2, County Dublin, Ireland 2 weeks ago
FS Business Consulting - Finance & Risk Regulatory Reporting - Manager - Dublin Dublin 2, County Dublin, Ireland 18 hours ago
Product Owner Global Regulatory Affairs (m/f/d) Dublin, County Dublin, Ireland 2 months ago
Dublin, County Dublin, Ireland €40,000.00-€45,000.00 2 weeks ago
Complaints Program Manager, Regulatory Operations Dublin, County Dublin, Ireland 2 weeks ago
Dublin, County Dublin, Ireland 2 weeks ago
Manager - Regulatory Advisory for Banking & Capital Markets Dublin, County Dublin, Ireland 1 hour ago
Program Manager, Regulatory Information Response Dublin, County Dublin, Ireland 2 weeks ago
Senior Manager, Data Analytics and Insights (Regulatory Affairs) - MedTech Dublin, County Dublin, Ireland 15 hours ago
We're unlocking community knowledge in a new way.
Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr