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Product Development Engineer
Dublin
Dublin
Director of Quality Engineering
Limerick
Limerick
Manufacturing Shift Lead
Donegal
Donegal
Senior Validation Engineer
Limerick
Limerick
Senior Electronic Engineer
Dublin
Dublin
Biomedical Engineer
Dublin
Dublin
QC Bioassay Analyst (shift)
Carlow
Carlow
Associate Quality Specialist
Tipperary
Tipperary
Aseptic Process Owner Lead
Dublin
Dublin
Project Engineer
Limerick
Limerick
Senior Validation Engineer
Limerick
Limerick
Senior Quality Engineer
Leitrim
Leitrim
Engineering Projects Lead
Carlow
Carlow
Strategic Automation Lead
Waterford
Waterford
Senior Operations Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Quality Technician
Dublin
Dublin
Production Operator
Carlow
Carlow
LIMS Analyst
Cork
Cork
Senior Mechanical Engineer
Dublin
Dublin
Quality Manager
Clare
Clare
Quality Technician
Carlow
Carlow
Quality Systems Specialist
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Associate Quality Specialist
Tipperary
Tipperary
Senior Operations Engineer
Galway
Galway
Senior QA Associate
Cork
Cork
Senior QC Associate
Dublin
Dublin
Maintenance CMMS Engineer
Tipperary
Tipperary
R&D Director
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Supply Chain Planner
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Waterford
Electrical Engineer
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Limerick
QA Engineer
Leitrim
Leitrim
Process Engineer
Limerick
Limerick
R&D Manager
Galway
Galway
Associate Global Trade Ops
Dublin
Dublin
Manufacturing Technician
Clare
Clare
Senior Engineering Manager
Limerick
Limerick
Operations Specialist
Louth
Louth
Senior R&D Engineer
Dublin
Dublin
Senior Regulatory Affairs
Galway
Galway
Clinical Project Manager
Dublin
Dublin
Quality Manager - NPI
Dublin
Dublin
Process Support Specialist
Carlow
Carlow
Process Support Specialist
Carlow
Carlow
Senior R&D Manager/Director
Dublin
Dublin
Process Engineer
Galway
Galway
R&D Manager
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Regulatory Affairs Manager
Dublin
Dublin
Senior Electronics Engineer
Dublin
Dublin
Medical Device Director
Republic of Ireland
Republic of Ireland
Production Operator
Carlow
Carlow
Engineering Specialist - Greece
Republic of Ireland
Republic of Ireland
Principal R&D Engineer
Galway
Galway
Product Development Engineer
Galway
Galway
Project Process Engineer
Carlow
Carlow
E&I Turnover Engineer
Carlow
Carlow
Program Manager
Cork
Cork
Project Engineer
Tipperary
Tipperary
Engineering Lead - Greece
Republic of Ireland
Republic of Ireland
Suite Team Delivery Lead
Tipperary
Tipperary
R&D Senior Program Manager
Galway
Galway
Electronic Design Engineer
Galway
Galway
Project Manager
Limerick
Limerick
Electrical Engineer
Cork
Cork
Validation Engineer
Limerick
Limerick
Senior Quality Engineer
Dublin
Dublin
Maintenance Engineer
Cork
Cork
Change Control Coordinator
Carlow
Carlow
R&D Engineer
Dublin
Dublin
Project Enginer
Dublin South
Dublin South
Senior R&D Engineer
Dublin
Dublin
Aseptic Process Lead
Carlow
Carlow
Principal R&D Engineer
Dublin
Dublin
Project Manager - Suite Lead
Tipperary
Tipperary
C&Q Lead
Tipperary
Tipperary
Senior Validation Engineer
Dublin
Dublin
Production Operator
Carlow
Carlow
Mechanical Design Engineer
Germany
Germany
Quality Manager - NPI
Dublin
Dublin
Senior QC 24/7 Shift
Dublin
Dublin
Quality Control Technician
Carlow
Carlow
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior Operations Engineer
Galway
Galway
R&D Manager
Galway
Galway
Embedded Software Engineer
Dublin
Dublin
Engineering Shift Technician
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
CQV Lead
Tipperary
Tipperary
QC Analyst
Meath
Meath
Senior Technical Writer
Dublin
Dublin
Product Development Engineer
Galway
Galway
EHS Specialist
Carlow
Carlow
Senior Design Engineer
Dublin
Dublin
Senior Technical Writer
Dublin
Dublin
Biomedical Engineer
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Senior R&D Engineer
Clare
Clare
Engineering Business Manager
Dublin
Dublin
Packaging Engineer
Dublin
Dublin
Principal R&D Engineer
Galway
Galway
Quality Engineer
Galway
Galway
Maintenance Engineer
Carlow
Carlow
Recruitment Consultant
Wexford
Wexford
R&D Director
Galway
Galway
Senior Validation Engineer
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
Senior Quality Engineer
Galway
Galway
Engineering Manager
Clare
Clare
EHS Systems Specialist
Dublin
Dublin
Project Engineer
Westmeath
Westmeath
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
Senior R&D Engineer
Galway
Galway
Product Development Engineer
Galway
Galway
Quality Technician
Dublin
Dublin
Product Development Engineer
Galway
Galway
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
Quality Engineer
Wexford
Wexford
E&I Turnover Engineer
Carlow
Carlow
Injection Moulding Engineer
Leitrim
Leitrim
Facilities Engineer
Carlow
Carlow
Principal R&D Engineer
Dublin
Dublin
Head of R&D
Galway
Galway
Quality Engineer
Athlone
Athlone
R&D Director
Galway
Galway
QC Lab Technician
Carlow
Carlow
Quality Control Technician
Carlow
Carlow
Specialist Operations Engineer
Tipperary
Tipperary
Qualified Person
Limerick
Limerick
Project Engineer
Republic of Ireland
Republic of Ireland
Senior Electronic Engineer
Dublin
Dublin
Maintenance CMMS Engineer
Tipperary
Tipperary
Senior R&D Engineer
Galway
Galway
Quality Technician
Dublin
Dublin
R&D Manager
Galway
Galway
Quality Validation Engineer
Limerick
Limerick
Project Manager - R&D
Galway
Galway
Senior Electrical Engineer
Galway
Galway
Operations Lead
Dublin South
Dublin South
Product Development Engineer
Dublin
Dublin
QC Chemistry Analyst (Shift)
Carlow
Carlow
Microbiology Manager
Dublin
Dublin
Chemical Engineer
Tipperary
Tipperary
Quality Technician
Dublin
Dublin
Process Development Engineer
Galway
Galway
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Quality Systems Specialist
Carlow
Carlow
Project Engineer
Roscommon
Roscommon
Senior QC Associate
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Automation Engineer
Cavan
Cavan
Pharmaceutical Operator
Louth
Louth
Validation Engineer
Cork
Cork
EHS Project Lead
Cavan
Cavan
Validation Engineer
Carlow
Carlow
Senior Quality Engineer
Limerick
Limerick
Senior R&D Project Manager
Galway
Galway
Facilities Engineer
Carlow
Carlow
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Quality Specialist
Tipperary
Tipperary
Process Engineer
Cork
Cork
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Process Support Specialist
Carlow
Carlow
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Dublin
Dublin
Senior R&D Engineer
Clare
Clare
QC Laboratory Technician
Carlow
Carlow
Quality Systems Manager
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
Project Engineer
Clare
Clare
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
Microbiology Technician
Dublin
Dublin
QA Specialist
Cork
Cork
Sourcing Specialist
Tipperary
Tipperary
Recruitment Consultant
Republic of Ireland
Republic of Ireland
Biostatistician
Dublin City Centre
Dublin City Centre
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Galway
Galway
Manager/ Senior Manager Drug Product Man
Republic of Ireland
Republic of Ireland
Clean Utilities Engineer
Carlow
Carlow
Quality Systems Enginer
Dublin
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Manufacturing Engineer
Limerick
Limerick
Quality Engineer
Athlone
Athlone
EHS Systems Specialist
Carlow
Carlow
Quality Manager
Dublin
Dublin
Senior Quality Engineer
Leitrim
Leitrim
Senior R&D Engineer
Galway
Galway
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Process Engineer (Shift)
Carlow
Carlow
Principal Process Equipment Engineer
Dublin South
Dublin South
Clean Utilities Engineer
Carlow
Carlow
R&D Director
Galway
Galway
R&D Chemist
Cork
Cork
Senior Associate Quality Control
Dublin South
Dublin South
Design Assurance Engineer
Galway
Galway
R&D Program Manager - Senior
Galway
Galway
Maintenance Reliability Engineer
Tipperary
Tipperary
Validation Lead
Dublin
Dublin
QC Bioanalytical Analyst
Dublin
Dublin
Quality Engineer
Galway
Galway
Quality Manager
Dublin
Dublin
Senior Electronic Engineer
Dublin
Dublin
Senior HVAC Engineer
Dublin
Dublin
R&D Program Manager
Dublin
Dublin
Maintenance Planner
Carlow
Carlow
Graduate Laboratory Technician
Republic of Ireland
Republic of Ireland
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Manufacturing Engineer
Wexford
Wexford
Search Results for Regulatory Affairs Manager
Job Title. | Location | Salary | Actions |
Senior Regulatory Affairs SpecialistJob title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1 day a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to the Se...Location: Athlone, Clare, Connaught, Galway, Galway City, |
EU | Not Disclosed | |
Senior Regulatory Affairs SpecialistJob title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to the Senior Reg...Location: Athlone, Clare, Connaught, Galway, Galway City, |
EU | Not Disclosed | |
CMC Pre-Approval Regulatory ScientistCMC Pre-Approval Regulatory Scientist Our client, a global pharma company, are currently recruiting for a CMC Pre-Approval Regulatory Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts.. As CMC Pre-Approval Regulatory Scientist, you will partner with Global Regulatory Affairs – CMC (GRA-CMC) Regulatory Scientists to provide strategic, tactical and operational direction and support to expedite CMC development of the organisations portfolio by developing successful regul...Location: Cork, |
Cork | Not Disclosed | |
Principal Scientist Global Regulatory Affairs CMCPrincipal Scientist- Global Regulatory Affairs-CMC Our client, a global pharma company, are currently developing a state-of-the-art biotech manufacturing facility based in Limerick (hybrid working) and are currently recruiting for a Principal Scientist- Global Regulatory Affairs-CMC to join their team on a permanent basis. As Principal Scientist- Global Regulatory Affairs-CMC you will provide strategic, tactical and operational direction to expedite the CMC development of the organisations portfolio and technical agenda by supporting global clinical trial, market registration...Location: Limerick, |
Limerick | Not Disclosed | |
Regulatory Affairs ManagerRegulatory Affairs Manager Our client, a pharma organisation, are currently recruiting for a Regulatory Affairs Manager to join their team on a permanent basis with hybrid working. Experience working with oral solid dosage (OSD) forms is essential for this role. You will work with a small team in Ireland and other team members across the UK and EU. Responsibilities Advise and liaise services on behalf of company to ensure that requirements of national competent authorities are met Create, assemble, review and publish regulatory submissions in accordance with agreed ...Location: Dublin, |
Dublin | Not Disclosed | |
CMC Regulatory Principal ScientistCMC Regulatory Principal Scientist Our client, a global pharma company, are currently recruiting for a CMC Regulatory Principal Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts. This role offers hybrid working. As CMC Regulatory Principal Scientist, you will lead various aspects of the global marketing authorization submission management processes, help manage submission content for Drug Substance and Drug Product, provide guidance on structure and content placement within CTD registration...Location: Cork, |
Cork | Not Disclosed | |
CMC Regulatory Senior ScientistCMC Regulatory Senior Scientist Our client, a global pharma company, are currently recruiting for a CMC Regulatory Senior Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts. This role offers hybrid working. As CMC Regulatory Senior Scientist, you will lead various aspects of the global marketing authorization submission management processes, help manage submission content for Drug Substance and Drug Product, provide guidance on structure and content placement within CTD registration submissi...Location: Cork, |
Cork | Not Disclosed | |
Senior Regulatory Affairs SpecialistJob title: Senior Regulatory Affairs Specialist – Post market Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Rep...Location: Athlone, Clare, Connaught, Galway, Galway City, |
EU | Not Disclosed | |
Senior Reg Affairs Specialist - Post MarketJob title: Senior Regulatory Affairs Specialist – Post market Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to t...Location: Galway, Galway City, |
Galway | Not Disclosed | |
Senior Regulatory Affairs SpecialistJob title: Senior Regulatory Affairs Specialist – Premarket Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Company: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. This role is best suited to an individual who is self-motivated, accountable and seeking infinite learning and growth opportunities. Role: As a Senior Regulatory Affairs Specialist you will will pl...Location: Clare, Connaught, Galway, Galway City, Limerick, |
EU | Not Disclosed | |
Quality Manager - NPIRole: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution, excellent opportunity to expand your career in exciting Medical Device company growing from strength to strength. Company: My client have deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adherence to al...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South, |
EU | Not Disclosed | |
Quality Manager - NPIRole: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution, excellent opportunity to expand your career in exciting Medical Device company growing from strength to strength. Company: My client have deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adherence to al...Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South, |
EU | 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
Quality Control Academic PhD Pharmaceutical Academic Sales and Marketing Supply Chain Microbiology Limerick Scientist Packaging Engineer IT Manufacturing Executive Pharma Sales Allied Healthcare Product Development Engineer Clinical Research Medical Affairs Medical Device Validation Engineer Laboratory Scientist Engineering Sales and Marketing Mayo Supply Chain Quality Engineering Project Manager Biotechnology Diagnostics Connected Health Chemistry Scientific Dublin Cork City Biopharmaceutical Life Science Quality Assurance Cork
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS