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R&D Manager
Galway
QP Manager
Dublin
QC Scientist
Limerick
eClinical Project Coordinator
Republic of Ireland
QA Manager
Dublin
Project Manager
Limerick
Qualified Person
Waterford
Clinical Research Associate (CRA)
Republic of Ireland
Quality Engineer
Limerick
Technical Writer
Limerick
R&D Manager
Limerick
Process Engineer
Dublin North
Senior Planner
Limerick
C&Q Engineer
Dublin
Validation Lead
Limerick
Project Engineer
Limerick
QA Manager
Cavan
Business Program Lead - Remote
Republic of Ireland
Project Engineer
Limerick
Head of R&D
Galway
Project Engineer
Limerick
Process Engineer
Limerick
eClinical Project Manager
Republic of Ireland
R&D Engineer
Limerick City
Senior R&D Engineer
Limerick City
Consultant




Search Results for Regulatory Affairs Manager
Job Title. Location Salary Actions

Senior Quality and Regulatory Manager

Senior Quality & Regulatory Manager Our client a growing Irish Med Tech company who have developed a technology that changes peoples lives currently seeks a Senior Quality and Regulatory Manager to join their team. The Senior Quality and Regulatory Manager will be required to lead the company wide Quality Management system ensuring they meet design specifications and standards for products and services. The role also has responsibility for regulatory clearance and compliance in target and existing markets, as well as providing technical support and guid...

Location: Galway,
Senior Quality and Regulatory Manager
Galway 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

Regulatory Delivery Excellence Manager

Regulatory Delivery Excellence Manager Our client, a Cork based pharmaceutical organisation are currently recruiting for a Regulatory Delivery Excellence Manager to join their team on a permanent basis. As Regulatory Delivery Excellence Manager you will be responsible for the recruitment, retention and resource assignment of the regulatory associates managing submissions in the Global Regulatory Affairs organization. You will provide leadership, direction, as well as technical / process expertise to the regulatory associates responsible for the regulatory submission management p...

Location: Cork,
Regulatory Delivery Excellence Manager
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

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

CMC Regulatory Specialist

CMC Regulatory Specialist 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 regarding the regulatory documentation, reporting requirements and registration processes in global markets. ...

Location: Cork,
CMC Regulatory Specialist
Cork Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Senior Regulatory Affairs Specialist Westmeath Not Disclosed
CMC Regulatory Specialist Cork Not Disclosed
Senior Regulatory Affairs Specialist Westmeath Not Disclosed
CMC Regulatory Associate Cork Not Disclosed
CMC Regulatory Associate Cork Not Disclosed
CMC-Development Regulatory Associate Cork Not Disclosed
CMC Regulatory Associate Cork Not Disclosed

Regulatory Affairs Manager Career Profile

Regulatory Affairs Manager


This role is normally suited to someone with a minimum of 5 years in a Regulatory setting, ideally more. Management, departmental budgeting, training are some of the keys tasks involved on the non-technical side of the role.

Key Responsibilities

  • Coordinating, compiling and submitting Marketing Authorisation variations for existing approvals
  • Composing and reviewing Pre-IND information packages and NDA packages for registration of prescription products in the US through the FDA
  • Liaise with partner companies as the primary Regulatory Affairs contact for the company to achieve product registration in all new worldwide regions within projected timeframes
  • Regulatory Affairs European project team leader for all new projects
  • Interpreting EU and US regulatory guidelines and procedures and ensuring the regulatory compliance of the company in all new regions Establish and analyse department budget
  • Identify and recommend areas for cost savings from and Regulatory and compliance perspective
  • Provide Regulatory advice and feedback for all internal company departments and external partners
  • Maintain and apply a high level of awareness and understanding of the impact of existing and future planned regulations