Regulatory Affairs Director

Job Title: Regulatory Affairs Director
Contract Type: Permanent
Contact Name: Gerry Kennedy
Contact Email:
Job Published: over 6 years ago

Job Description

Director Regulatory Affairs Dublin

Our client is a major multinational pharmaceutical company enjoying exceptional growth.

Job Spec : Director of Regulatory Affairs

Point of contact with EMA/CHMP and national competent authorities. Primary liaison/point of contact. Coordinate face-to-face regulatory interactions with local competent authorities.
Serve as resource for knowledge about EU regulatory environment to global regulatory teams.

Assist teams with development of EU regulatory strategy.
Review regulatory documents with respect to consistency with EU regulatory strategy and compliance with EU regulatory requirements.
Liaison with CROs working in the EU with respect to regulatory issues.
Oversee regulatory staff, including regulatory operations staff, and interface with HQ on their projects.
Provide local regulatory guidance as needed and represent regulatory management to local CMC and other groups, including QPs for manufacturing and pharmacovigilance.

Solid line reporting to VP Head of Regulatory Affairs.

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