Regulatory Affairs Manager - NEW OPPORTUNITY
2 days 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 [email protected] or call Tina at +353 1 2784701
Thornshaw Scientific is a leading life sciences agency and part of the CPL Group of companies.
www.thornshaw.com
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Legal
* Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at Cpl by 2x
Get notified about new Regulatory Affairs Manager jobs in Dublin, County Dublin, Ireland.
Dublin, County Dublin, Ireland 1 week ago
Senior Manager - Head of Compliance (PCF 12 / PCF 52), Etsy Payment Ireland Limited
Dublin, County Dublin, Ireland 2 weeks ago
Dublin, County Dublin, Ireland 2 weeks ago
Dublin, County Dublin, Ireland 1 week ago
Dublin, County Dublin, Ireland 1 week ago
Dublin, County Dublin, Ireland 17 hours ago
Dublin, County Dublin, Ireland 3 days ago
Dublin, County Dublin, Ireland 2 weeks ago
Compliance & Risk Manager, AIFM (4 or 5 days) exclusive role
Dublin, County Dublin, Ireland 2 weeks ago
Dublin, County Dublin, Ireland 4 days ago
Dublin, County Dublin, Ireland 2 weeks ago
Dublin, County Dublin, Ireland 1 week ago
Dublin, County Dublin, Ireland 1 week ago
Regional AML Compliance Manager - Ireland
Dublin, County Dublin, Ireland 2 weeks 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