Global Regulatory Strategy Director - Shape Drug Approvals

BioSpace

Florham Park (NJ)

On-site

USD 180,000 - 240,000

Full time

4 days ago

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Job summary

AbbVie is seeking a Director Regulatory Affairs Global Regulatory Lead to develop and implement global strategies for market approval and lifecycle management. You will lead cross-functional teams, manage regulatory risks, and ensure regulatory compliance across development and post-approval stages.

The role requires 7+ years in regulatory roles, with leadership experience and strong communication skills. This is a high-impact, matrix-managed position within AbbVie’s Regulatory Affairs

Qualifications

Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
7+ years regulatory experience, US & C region drug development experience.
Proven 5+ years in a strategic leadership role with strong project management skills.

Responsibilities

Lead the Global Regulatory Product Team to develop global strategies aligned with applicable regulations and business objectives.
Lead cross-functional stakeholders to ensure clear strategic messaging in global regulatory dossiers and responses to agency requests.
Accountable for regulatory policy and strategy for assigned products and ensure alignment with senior management.
Mentor GRPT members and influence regulatory policy and guidance across regions.

Skills

Regulatory leadership

Strategic leadership

Project management

Communication

Negotiation

Education

Bachelor's degree in life sciences

Job description

The role requires 7+ years in regulatory roles, with leadership experience and strong communication skills. This is a high-impact, matrix-managed position within AbbVie’s Regulatory Affairs

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