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Regulatory affairs programme lead

Cork
beBeeProject
Posted: 14 November
Offer description

Regulatory Affairs Project Manager EMEA

The role involves leading the execution of complex projects that require coordination and functional integration across the EMEA region.

* Manage registration plans for assigned franchises, ensuring high-quality regulatory dossiers and timely approvals/renewals.
* Promote business growth through strategic project management and regulatory processes.
* Develop, implement, and maintain harmonized market clearance/registration processes across Europe, Middle East, and Africa.

Main responsibilities include:

* Managing project scope, deliverables, resources, schedules, and budgets.
* Ensuring RA execution throughout all phases of the product lifecycle.
* Collaborating with RAQA management and International RA teams to develop submission strategies.

This position requires a strong background in regulatory affairs, project management, and team leadership. The ideal candidate will have a Bachelor's degree in a related field and at least 4 years of relevant experience, including demonstrated project management experience and PMP certification or equivalent. The successful candidate will be able to effectively manage multiple priorities, communicate with cross-functional teams, and provide solutions-driven insights.

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