Senior Director, Global Regulatory Strategy

AbbVie; Irvine (CA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Director Regulatory Affairs Global Regulatory Lead to develop and implement global strategies to secure and maintain market approval for products. You will lead the Global Regulatory Product Team and manage regulatory life cycle strategies across development and post-approval stages.

You will mentor GRPT members, coordinate with cross-functional teams, and influence regulatory policy worldwide while ensuring alignment with senior management and business objectives.

Qualifications

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
• Relevant advanced degree is preferred. Certification a plus.
• 7+ years regulatory experience in US & C region; strong leadership and project management.

Responsibilities

• Interfaces with LRST and AST to lead and support cross-functional objectives.
• Leads cross-functional stakeholders to ensure strategic messaging in global regulatory dossiers.
• Accountable for ensuring corporate goals are met and regulatory policy is driven.
• Leads preparation of global regulatory product strategies and risk mitigation plans.
• Participates in or leads regulatory initiatives and mentors team members.
• Influences the development of regulations and guidance with worldwide accountability for assigned products.
• Ensures alignment of global regulatory strategies with senior management and communicates issues to stakeholders.
• Chairs or sponsors key regulatory initiatives and manages resource planning.

Skills

Global Regulatory Strategy

Leadership

Cross-functional collaboration

Regulatory submissions

Education

Bachelor's degree in life sciences

Job description

AbbVie is seeking a Director Regulatory Affairs Global Regulatory Lead to develop and implement global strategies to secure and maintain market approval for products. You will lead the Global Regulatory Product Team and manage regulatory life cycle strategies across development and post-approval stages.

You will mentor GRPT members, coordinate with cross-functional teams, and influence regulatory policy worldwide while ensuring alignment with senior management and business objectives.