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R&D Engineer
Dublin City Centre
R&D Engineer
QA Manager
Dublin West
Snr QA Officer
Dublin North
QA Manager Biologics
Dublin West
Product Specialist (Microbiology)
Republic of Ireland
API Purchaser
QA Manager
Dublin North
Program Manager
QA Manager
Head of Quality
Dublin West
Senior CRA
Snr QA Specialist
Dublin South
Brian Christensen
Life Science

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

Regulatory Affairs & Labelling Specialist

Regulatory Affairs & Labelling Specialist Our client, a Irish owned organisation are currently recruiting for a Regulatory Affairs and Labelling Specialist to join their team. This is a permanent opportunity and the successful candidate will report directly into the Head of Quality and Regulatory Affairs. Responsibilities ·Execute and complete tasks and deliverables for CE marking activities as required to IVD directive ·Provide update and maintain status of product registration and notifications ·Provide documentation and certifications upo...

Location: Tipperary,
Regulatory Affairs & Labelling Specialist
Tipperary Not Disclosed

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

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist Job purpose: The Sr. Regulatory Affairs Specialist will develop strategies for complex projects and issues related to regulatory processes, compliance activities, documents, submissions, investigations, product development planning and regulatory agency interaction. The Sr. Regulatory position will assist in mentoring and development of staff members as part of the role. Key responsibilities: • Key responsibilities will include (but are not limited to) the following: • Support global regulatory projects,...

Location: Westmeath,
Senior Regulatory Affairs Specialist
Westmeath 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 Regulatory Compliance Officer

Senior Regulatory Compliance Officer Our client, a global healthcare organisation, requires a Senior Regulatory Compliance Officer to join their team for fixed term contract, the duration of which is 6 months. The successful candidate will manage, review registration information and provide this information to relevant departments, and to ensure regulatory compliance for all products released. Responsibilities • Manage the review of registration information supplied by various regional registration centres and provide the information as appropriate to the relevant...

Location: Dublin,
Senior Regulatory Compliance Officer
Dublin Not Disclosed

Regulatory Affairs Specialist

REGULATORY AFFAIRS SPECIALIST Our client a Galway based medical device start up company is recruiting an RA Specialist. The successful candidate will work on

Location: Galway,
Regulatory Affairs Specialist
Galway Not Disclosed
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Regulatory Affairs Specialist Career Profile

Regulatory Affairs Specialist

There are Regulatory Affairs (RA) opportunities available in a variety of industries: Pharmaceutical / Biotech / Agrochemical / Clinical Research Organisations (CRO's). There also exist roles in Consultancy organisations, companies which service small and large Clients in the above industries, on various projects. These can often be interesting and varied roles for the experienced RA professional.

Salary Scale:

  • Regulatory Affairs Assistant - €25,000 - €28,000
  • Regulatory Affairs Officer - €32,000 - €39,000
  • Regulatory Affairs Specialist - €40,000 - €55,000
  • Regulatory Affairs Manager - €60,000 - €80,000
  • Regulatory Affairs Director - €85,000 +

Role Responsibilities:

  • Life cycle management and Maintenance of regulatory filings including annual reports and supplements to US FDA.
  • Preparation of registration submissions, in CTD (Clinical Trial Dossier) format, for pharmaceutical products for approval by the US FDA, European Regulatory Authorities and worldwide, as required.
  • Monitoring the progress of registration submissions, responding to queries and ensuring that registration approvals are granted without undue delays.
  • Regulatory Compliance, for change control activities monitoring the impact of changes in regulatory submissions.
  • Monitoring adverse events for submissions, preparation and review and generation of supporting documents for potential field alerts and recalls.
  • Maintenance of approvals, including the preparation of annual reports for US products.
  • Assess and review documentation to ensure compliance with product licences.
  • Undertake general regulatory activities that interface with other departments such as Manufacturing, Product Development, Quality Control and Quality Assurance.
  • Actively participate in project teams, as required.

Industry Experience:

  • Minimum of 3 years regulatory experience in the pharmaceutical industry.
  • Knowledge of the current regulatory requirements, particularly US and EU.
  • Experience in writing and submitting regulatory documentation.