Regulatory affairs officers new december 24 Jobs in Dublin
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Regulatory affairs officers new december 24 • Dublin
- Promoted
Associate Director Regulatory Affairs
Quanta Consultancy Services LtdDublin, IrelandTelecoms Access Officers
EntegroDublin West, Dublin, Republic of IrelandRegulatory CMC Specialist
Helsinn Birex Pharmaceuticals LtdDublin, Leinster, Republic of IrelandRegulatory Director
KPMG IrelandDublin, IrelandRegulatory Specialist
APC LtdDublin, IrelandRegulatory Affairs Project Manager
ParexelDublin, IrelandSales Executive – Life Sciences – Regulatory and Safety Technology Solutions
IQVIADublin, IrelandRegulatory Affairs Manager - NEW OPPORTUNITY
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WingJet AviationDublin, GB- Promoted
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AvatureDublin, IrelandRegulatory Compliance
Arcadis DPSDublin, Leinster, Republic of Ireland- Promoted
Senior Regulatory Reporting Analyst New Ireland
MonzoDublin, IrelandEASA A320 First Officers | Avion Express
Avion ExpressDublin, GB- Promoted
Global Head Of Regulatory Affairs
Azurity PharmaceuticalsDublin, Ireland- Promoted
Regulatory Manager
Mark Anthony GroupDublin, IrelandAssociate Director Regulatory Affairs
Quanta Consultancy Services LtdDublin, IrelandAssociate Director Regulatory Affairs - Ireland, Dublin - 12 Month Contract
Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation?
We are recruiting for aAssociate Director Regulatory Affairs to support the Dublin function. Essential duties and responsibilities for this role include, but are not limited to, the following : Developing and implementing global regulatory strategies for assigned products.
Providing regulatory strategic oversight for projects in the relevant therapeutic areas / portfolio, as assigned, aligned to overall Enterprise objectives through initial registration and subsequent lifecycle management.
Providing input to submission strategy and other critical regulatory documents.May act as the point of contact with relevant Health Authorities and / or lead interactions with such authorities or other relevant external stakeholders.
May provide input to internal governance and advisory bodies from which GRA staff can seek insight on strategic and procedural / operational issues as they arise.
Actively being up to date on latest regulatory requirements and trends and contribute to the shaping of the regulatory science environment.
Support regulatory intelligence and policy priorities based on internal knowledge and expertise.
Ensuring exemplary behavior, leadership, ethics and transparency within the Enterprise, with Health Authorities and other external stakeholders.
Desirable experience : Extensive Regulatory experience in the pharmaceutical industry, with significant track record on Global Strategies.
Strong knowledge of drug development and regulatory policy, coupled by excellent scientific and business judgement.
Experience providing strategic regulatory advice for the global development of products through all stages of development including marketed assets.
Successful track record in registering and overseeing regulatory strategies for assets.
Bachelor's Degree, life science highly desirable Postgraduate degrees relevant to the role (e.g.
MSc, PhD) a plus If this role is of interest, please apply now.
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