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QA Manager Biologics
Dublin West
Market Access Manager
Dublin City Centre
QA Manager
Dublin West
Snr QA Specialist
Dublin South
Biostatistician
Dublin City Centre
Snr Process Engineer
Dublin North
Product Specialist (Microbiology)
Republic of Ireland
R&D Engineer
Galway
QA Manager
Meath
QA Manager
Dublin North
QP Biologics
Dublin
Program Manager
Westmeath
Consultant
Brian Christensen
Life Science

+353 (0)1 685 47 47
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Search Results for Regulatory Affairs Manager
Job Title. Location Salary Actions

Senior CMC Reg Affairs Specialist

Senior CMC Reg Affairs Specialist Our client is an organisation with a focus on the development and manufacture of generic pharmaceutical products. They are currently recruiting for a Senior CMC Reg Affairs Specialist to join their team based in Dublin. The successful candidate will report directly to the Head of Regulatory Affairs. The role will include some travel. Responsibilities • Critical review of high quality, Chemistry Manufacturing and Control (CMC) detailed regulatory documents and identify any possible deficiencies prior to dossier submission to EU and US A...

Location: Dublin,
Senior CMC Reg Affairs Specialist
Dublin Not Disclosed

Regulatory Affairs Manager (Food)

Our client is a world leader in the Food sector. They are currently seeking an experienced Regulatory Manager to manage and develop a team of Regulatory Technologists, Senior Technologists and Specialists. The successful person shall improve regulatory processes, ensuring efficient, accurate and timely delivery of technical documentation to customers across EMEA. They will also ensure that products meet national and international legislation requirements. Role/Responsibilities: • Full understanding of relevant regulations globally - with a particular focus on EU, M...

Location: Kildare,
Regulatory Affairs Manager (Food)
Kildare Not Disclosed

Head of Quality & Regulatory Affairs

Head of Quality & Regulatory Affairs Our client a multinational healthcare company currently seeks Head of Quality and Regulatory Affairs. Reporting to Ge

Location: Dublin,
Head of Quality & Regulatory Affairs
Dublin Not Disclosed

Active Devices Product Technical Specialist / Scheme Manager

We are currently working on an exciting opportunity with world renowned notified body. Who are seeking a Technical Specialist/Scheme Manager in the area of Acti

Location: Republic of Ireland,
Active Devices Product Technical Specialist / Scheme Manager
Republic of Ireland Not Disclosed
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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