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Search Results for for
Job Title. Location Salary Actions

Regulatory Scientist

Regulatory Scientist Our client a medical device multinational currently seeks a Regulatory Scientist to join their team. The Regulatory Scientist will develop and manage a variety of reports involving clinical data analyses and review, collaborate and provide clinical research support to cross-functional product development teams and other functions, as necessary. Role/Responsibilities: • Develop and manage Post-Market Surveillance Plans (PMSPs), Clinical Evaluation Reports (CERs), Literature Reviews, Clinical Risk Benefit ...

Location: Westmeath,
Regulatory Scientist
Westmeath Not Disclosed

Senior Manager, Quality Assurance (External Manufacturing)

Our client is a Global Biopharma with extensive Manufacturing & Global operations in Cork. They are seeking a Senior Manager, Quality Assurance for their Cork operations. The person shall have a strong QA Biopharma/Pharma background. External Manufacturing experience & CMO experience is a distinct advantage. Managing CMO’s mainly based out of Europe but, there may be a need to support outside of Europe if needed. This role will not have any direct reports, it will be an individual contributor role. Injectables & drug product experience a distinct ad...

Location: Cork,
Senior Manager, Quality Assurance (External Manufacturing)
Cork Not Disclosed

Director of Regulatory Affairs

Our client a high potential medical device start up is currently seeking a Director of Regulatory Affairs to join their team. Reporting to the CEO the Regulatory Affairs Director will be Responsible for leading the Regulatory strategy and submissions, in multiple jurisdictions, to progress Clinical and Regulatory approvals through to a fully developed, market approved device. Role/Responsibilities Provides Regulatory leadership for the development and clinical teams. Develops innovative and effective worldwide Regulatory strategies for the product roadmap. Pr...

Location: Dublin,
Director of Regulatory Affairs
Dublin Not Disclosed

Manager, Clinical Data Management

Our client is a Global Biopharma who are establishing a Paediatric Centre of Excellence in Dublin that will be responsible for the management and execution of Paediatric Clinical Trials, across all therapeutic areas, around the world. The Clinical Operations team in Dublin is a pivotal function within this Centre of Excellence. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory gui...

Location: Dublin,
Manager, Clinical Data Management
Dublin Not Disclosed

CMC Regulatory Specialist

CMC Regulatory Specialist required for a contract role with a Cork based Pharmaceutical client. Role Summary: Our client, a global pharma company are currently recruiting for a CMC Regulatory Specialist to join their team on a permanent basis.As CMC Regulatory Specialist you will support new product approvals, existing product renewals, and post-approval changes for global registrations, through document distribution and internal database maintenance. You will closely with regulatory product representatives providing guidance to them rega...

Location: Cork,
CMC Regulatory Specialist
Cork Not Disclosed

Senior Manager, Quality Control (Biologics)

Our client is a Global Biopharmaceutical, based in Cork. They are in the planning & development stage of expanding their laboratory capabilities so they will test the Biologics manufactured in the European market. With the development of new Bio-assay labs & a Microbiology suite they are now looking to appoint a new position of Senior Manager, Quality Control. This QC Sr Manager role requires significant expertise/specialisation in Biological Product testing. You will be responsible for start-up and development of a Biologics potency laboratory, equipment p...

Location: Cork,
Senior Manager, Quality Control (Biologics)
Cork Not Disclosed

Director Regulatory Affairs

Director Regulatory Affairs Our client, a growing biotech organisation are currently recruiting for a Director of Regulatory Affairs to join their organisation on a permanent basis. As Director of Regulatory Affairs will be responsible for the coordination and the day-to-day support of the regulatory affairs strategy and operational activities of the organisation. You will provide support to both CMC, non-clinical, and clinical development. Responsibilities Coordinate input from external regulatory affairs consultants, identify and close knowledge gaps Provide regulatory...

Location: Dublin, Republic of Ireland,
Director Regulatory Affairs
Dublin Not Disclosed

Director of Regulatory Affairs

Our client a high potential medical device start up is currently seeking a Director of Regulatory Affairs to join their team. Reporting to the CEO the Regulatory Affairs Director will be Responsible for leading the Regulatory strategy and submissions, in multiple jurisdictions, to progress Clinical and Regulatory approvals through to a fully developed, market approved device. Role/Responsibilities Provides Regulatory leadership for the development and clinical teams. Develops innovative and effective worldwide Regulatory strategies for the product roadmap. Provi...

Location: Dublin,
Director of Regulatory Affairs
Dublin Not Disclosed

Regulatory Officer

Life Science Recruitment are exclusively sourcing a Regulatory Officer for our client who are based in Limerick. The ideal candidate will have a BSc in molecular science with the ability and confidence to undertake all associated responsibilities. Role/Responsibilities: Prepare and maintain IVDR compliant technical files utilising information from cross functional teams. Review and approve project documentation and participate in R&D phase reviews across multiple projects. Coordinate risk management activities and file preparation. Communicate specific regulatory req...

Location: Limerick,
Regulatory Officer
Limerick Not Disclosed

CMC-Development Regulatory Associate

CMC – Development Regulatory Associate Our client, a global pharma company are currently recruiting for a CMC Development Regulatory Associate to join their team on a permanent basis.As CMC Development Regulatory Associate you will create and manage submission documents and provide guidance on structure and content placement. You will work within regulations to expedite the registration and lifecycle maintenance of products, to ensure delivery of safe and effective products to patients.The scope of work includes global regulatory requirement assessment and understanding stra...

Location: Cork,
CMC-Development Regulatory Associate
Cork Not Disclosed

Senior Quality Assurance Specialist

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Dublin This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties •The Quality Assurance (QA) Specialist is a senior and active role within the broader QA function. •The QA Specialist will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility. •QA specialists will b...

Location: Dublin,
Senior Quality Assurance Specialist
Dublin Not Disclosed

Clinical Regulatory Associate

Clinical Regulatory Associate Our client, a global pharma company are currently recruiting for a Clinical Regulatory Associate to join their team on a permane

Location: Cork,
Clinical Regulatory Associate
Cork Not Disclosed

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist Our client a high potential medical device start up current seeks a Senior Regulatroy Affairs Specialist to join their team. Reporting to the Director of Quality and Regulatory Affairs the Senior Regulatory Affairs will take an active role in developing the Regulatory strategy in Europe and the US and interacting with the relevant Regulatory and Notified Bodies. They will also be required to help maintain the Design History Fileof Class III implant. This position offers the opportunity to join in an exciting early stage company developing a...

Location: Dublin,
Senior Regulatory Affairs Specialist
Dublin Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Senior Regulatory Affairs Specialist Dublin Not Disclosed
Clinical Regulatory Associate Cork Not Disclosed
Director of Regulatory Affairs Dublin Not Disclosed