Director, RA Global Regulatory Strategy

AbbVie

Director-level regulatory affairs position leading global strategy development and market approval efforts for neuroscience products. Responsible for managing cross-functional teams, regulatory dossiers, and lifecycle management while ensuring compliance with global regulations.

Responsibilities

Lead Global Regulatory Product Team to develop creative strategies aligned with business objectives
Develop and implement global regulatory product strategies for assigned products across lifecycle
Interface with cross-functional teams to ensure clear strategic messaging in regulatory dossiers
Proactively identify and mitigate regulatory risks; influence regulatory policy development
Present regulatory assessments and recommendations to executive management and senior stakeholders

Requirements

Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related field
7+ years pharmaceutical regulatory experience including US & C region drug development
5+ years strategic leadership role with strong project management capabilities
Experience interfacing with major government regulatory agencies
Strong global regulatory strategy development and implementation experience
Excellent communication and negotiation skills in complex matrix environments

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Vacancy posted 6 days ago

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