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Hot Regulatory Affairs Jobs

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Search Results for Regulatory Affairs Specialist

Job Title.	Location	Salary	Actions
Regulatory Officer Our client is an exciting entrepreneurial research & development driven organisation, based in Drogheda. They are seeking a Regulatory Officer for a 9 month contract to cover a maternity leave. This role is responsible for product registration and document control across all global brands and markets. The position requires significant organisation skills, with cross functional engagement to ensure relevant documents are supplied on time and to a high standard. Role/Responsibilities: Register products for new markets, maintain and sub... Location: Louth, Republic of Ireland, Regulatory Officer	Louth	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
Regulatory Officer Life Science Recruitment are exclusively sourcing a Regulatory Officer for our client who are based in Limerick. The ideal candidate will have a BSc in molecular science with the ability and confidence to undertake all associated responsibilities. Role/Responsibilities: Prepare and maintain IVDR compliant technical files utilising information from cross functional teams. Review and approve project documentation and participate in R&D phase reviews across multiple projects. Coordinate risk management activities and file preparation. Communicate specific regulatory req... Location: Limerick, Regulatory Officer	Limerick	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
CMC Regulatory Associate CMC Regulatory Associate Our client, a global pharma company are currently recruiting for a CMC Regulatory Associate to join their team on a permanent basis.As CMC Regulatory Associateyou will lead and partner with Chemistry, Manufacturing and Controls (CMC) Regulatory Scientists in the various aspects of global marketing authorization submission management processes. You will build and manage submission content, provide guidance on structure and content placement within Common Technical Document (CTD) registration submissions, and to provide assistance with submission rel... Location: Cork, CMC Regulatory Associate	Cork	Not Disclosed
CMC-Development Regulatory Associate CMC – Development Regulatory Associate Our client, a global pharma company are currently recruiting for a CMC Development Regulatory Associate to join their team on a permanent basis.As CMC Development Regulatory Associate you will create and manage submission documents and provide guidance on structure and content placement. You will work within regulations to expedite the registration and lifecycle maintenance of products, to ensure delivery of safe and effective products to patients.The scope of work includes global regulatory requirement assessment and understanding stra... Location: Cork, CMC-Development Regulatory Associate	Cork	Not Disclosed

Other Regulatory Affairs Jobs

Job Title	Location	Salary	Actions
Director of Regulatory Affairs	Dublin	Not Disclosed
Clinical Regulatory Associate	Cork	Not Disclosed
Senior Regulatory Affairs Specialist	Dublin	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.

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