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

Regulatory Affairs Manager

Regulatory Affairs Manager Our client requires a Regulatory Affairs Manager to joint their team. The ideal candidate will have excellent experience in the are

Location: Kerry,
Regulatory Affairs Manager
Kerry Not Disclosed

Regulatory Affairs Manager

Regulatory Affairs Manager Our client requires a Regulatory Affairs Manager to joint their team on a permanent basis. The ideal candidate will have excellent

Location: Kerry,
Regulatory Affairs Manager
Kerry Not Disclosed

Regulatory Affairs Manager

Regulatory Affairs Manager Our client is an international pharmaceutical discovery organisation and they are currently recruiting for a Regulatory Affairs Manager to join their team on a permanent basis. The ideal candidate will be a dynamic individual, who is self-driven, organized and capable of working on their own initiative in a start-up environment. Responsibilities • Coordinate, prepare and be accountable for all regulatory affairs related activities such as clinical trial applications, organization and preparation of regulatory advice meetings and compilation...

Location: Dublin,
Regulatory Affairs Manager
Dublin Not Disclosed

Senior Director, Regulatory Affairs

Our client is a Biopharma organization from the US with office based in Dublin in the last year. They are seeking a Senior Director of their Regulatory Affairs. The incumbent will be responsible for leading the Regulatory Affairs functions within Europe and specific additional regions. A scientific degree with a minimum of 5 years Regulatory experience (10 years Pharmaceutical experience) is required as a minimum. 20% travel associated with this role. Role/Responsibilities: • Ensure appropriate support for program maintenance, post-marketing studies and development ...

Location: Dublin,
Senior Director, Regulatory Affairs
Dublin Not Disclosed

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

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
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
CMC Regulatory Affairs Director Dublin Not Disclosed
Senior Regulatory Affairs Specialist Westmeath Not Disclosed
CMC Regulatory Affairs Director Dublin Not Disclosed
Senior Regulatory Affairs Specialist Westmeath Not Disclosed
Regulatory Affairs Specialist Galway Not Disclosed
Regulatory Affairs Specialist Galway Not Disclosed
Senior Regulatory Compliance Officer Dublin Not Disclosed
Senior Regulatory Compliance Officer Dublin Not Disclosed
Senior Regulatory Affairs Specialist Westmeath 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