Job Title.	Location	Salary	Actions
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
Regulatory Project Manager Regulatory Project Manager Our client, a growing biotech organisation are currently recruiting for a Regulatory Project Manager to join their organisation on a permanent basis. As Regulatory Project Manager you will be responsible for the coordination and the day-to-day support of the regulatory affairs strategy and operational activities of the organisation. As Regulatory Project Manager you will provide support to both CMC, non-clinical, and clinical development. Responsibilities Coordinate input from external regulatory affairs consultants, identify and close knowledg... Location: Dublin, Regulatory Project Manager	Dublin	Not Disclosed
Quality and Regulatory Affairs Manager Quality & Regulatory Affairs Manager Our client, a leading healthcare organisation are currently recruiting for a Quality and Regulatory Affairs Manager to join their team on a permanent basis. As Quality & Regulatory Affairs Manager you will be responsible for leading the regulatory affairs and quality assurance functions within the organisation. You will manage the department effectively to ensure compliance, continuous improvement and to ensure product quality and customer satisfaction. Responsibilities Provide Quality & Regulatory ... Location: Dublin, Quality and Regulatory Affairs Manager	Dublin	Not Disclosed

Other Regulatory Affairs Jobs

Job Title	Location	Salary	Actions
CMC-Development Regulatory Associate	Cork	Not Disclosed
CMC Regulatory Associate	Cork	Not Disclosed
Senior Regulatory Affairs Specialist	Dublin	Not Disclosed
CMC Regulatory Associate	Cork	Not Disclosed
CMC Regulatory Associate	Cork	Not Disclosed
Associate Compliance Specialist - Manufacturing	Limerick	Not Disclosed
CMC Regulatory Associate	Cork	Not Disclosed
Senior Director, Regulatory Affairs (Biopharma)	Dublin	Not Disclosed
CMC Regulatory Associate	Cork	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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CMC Regulatory Specialist

Regulatory Project Manager

Quality and Regulatory Affairs Manager

Regulatory Affairs Manager Career Profile

Regulatory Affairs Manager