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Excellent position for a capable regulatory project manager who can aid and drive forward activities to support expansion of drug registration into wider markets. You will be working with ground breaking drug candidates and managing regulatory submission projects across a broad range of geographies.

We are seeking candidates with solid regulatory management skills in R&D or product licensing. Current understanding of pharmaceutical product development in EU is essential to allow swift adaptation to in this role.

This role is a senior management role and will demand skill in negotiating with peers and managers across alldisciplines involved in making and maintaining regulatory authorisations.

This is a permanent role.

Principalduties are:
• Responsible for the regional strategy and execution of the preparation of International Market Applications and post-market supplements/variations.
• Executes CMC specific issues for international expansion strategy in InternationalMarkets.
• Participate in the development of product label by collaborating with the Labelling Working Group to define commercial objectives in the context of regulatory guidance and precedent.
• Contributes to CMC product teams and Global Regulatory Team (GRT) reports
• Provides guidance for change control regulatory assessments for products distributed in IE markets.
• Identifies and forms liaisons with local agents to act on Company's behalf with local regulatory authorities.
• Monitors the actions of local agents to assure approvable applications
• Provide guidance on regional regulatory mechanisms to optimize product registration
• Develop and maintain Marketing Authorization and Variation templates
• Provide guidance forimport/export of licensed and unlicensed products to international expansion regions