Job Title.	Location	Salary	Actions
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
Quality Assurance and Regulatory Affairs Manager Quality Assurance and Regulatory Affairs Manager Our client, one of the largest biomedical innovator based in Dublin is looking to recruit QA/RA Manager wh Location: Dublin North, Quality Assurance and Regulatory Affairs Manager	Dublin North	Not Disclosed
Regulatory Affairs & Quality Manager Regulatory Affairs & Quality Manager Description: Our client is a start-up medical device company based in Galway. They are seeking a highly experienced Location: Galway, Regulatory Affairs & Quality Manager	Galway	Not Disclosed
Regulatory Affairs & Quality Manager Regulatory Affairs & Quality Manager Description: Our client is a start-up medical device company based in Galway. They are seeking a highly experienced Location: Galway, Regulatory Affairs & Quality Manager	Galway	Not Disclosed
Regulatory Affairs Manager Regulatory Affairs Manager Our client, a global pharmaceutical organisation are currently recruiting for a Regulatory Affairs Manager to join their team. Thi Location: Dublin, Regulatory Affairs Manager	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

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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

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Regulatory Affairs Manager

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Regulatory Affairs Manager Career Profile

Regulatory Affairs Manager