Regulatory Affairs Leader

1 week ago


Dublin, Dublin City, Ireland beBeeRegulatory Full time €180,000 - €220,000
Job Description

Our company is seeking an experienced Regulatory Affairs Director (Europe) to lead our regulatory strategy and execution across European markets. This key leadership role is responsible for guiding products through clinical development, marketing authorization, and lifecycle management, while serving as the primary regulatory interface with EMA and national competent authorities.

This role involves leading the development and execution of European regulatory strategy in alignment with global objectives. It also requires overseeing preparation, submission, and maintenance of regulatory dossiers to ensure timely approvals.

The successful candidate will serve as the primary liaison with EMA and national health authorities, managing communications, negotiations, and regulatory interactions.

They will provide regulatory leadership and guidance during product development, registration, and post-market activities. Ensuring compliance with EU regulatory requirements, including applicable directives and guidelines, is also a key responsibility.

This position requires strong experience working in dynamic, cross-functional, and international environments.

It also demands exceptional communication, negotiation, and collaboration skills, with the ability to influence senior stakeholders.



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