An expanding specialist pharmaceutical organization who has grown significantly through acquisition in recent years is looking to hire a new Global Director Regulatory Affairs for the Dublin based EMEA headquarters. This organization currently has products in excess of thirty global products outside of the US and is looking to expand this product portfolio into new markets through M&A and also organic growth. As a result, they need to recruit a Global Director Regulatory Affairs to head up global function to ensure the company is compliant with all regulatory and compliance processes across multiple markets.

• This role will report into an SVP & Chief Medical Officer and will lead the Regulatory Affairs function globally.
• This role will oversee the regulatory strategy and implementation that incorporates risk identification and mitigation for programs at various stages of product life cycle including CMC activities and dossier content.
• This position will be focused on developing and maintaining strategic relationships with all agencies across all global markets to ensure compliance with commercial launches as the organization continues to expand through merger & acquisition.
• Manages regulatory CMC activities for product global expansion, in close collaboration with Regulatory International colleagues. Establishes best practice in developing and maintaining global CMC core dossier for each marketed product.
• This position works cross-functionally and serves as a liaison between the Regulatory team, Tech Ops, Clinical Operations, and other business functions for regulatory activities. This role also plays a key role in developing organizational capabilities for the regulatory department and RA CMC group

Experience Required:
Degree quailed with a science related area and 10-12 years plus regulatory affairs experience within the life science sector.
Demonstrated, hands-on experience in drug development, registration, and post-approval life cycle management in a global environment.
Demonstrated experience in preparing regulatory submissions, including IND/CTA, NDA/MAA, briefing documents, and response to agency queries.

The Next Step for you:
Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on 00 353 1662 9120
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