Director, Global Regulatory Strategy & Policy

Regulatory Jobs; Waltham (MA); On-site; USD 170,000 - 210,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

401(k)

Job summary

AbbVie seeks a Director Regulatory Affairs GRL II in Global Regulatory Strategy. The role develops and implements global strategies to secure and maintain market approvals, leads the GRPT, and collaborates with AST and cross-functional teams to mitigate regulatory risks.

You will drive global product strategies across development and lifecycle management, mentor team members, and influence regulatory policy at senior levels, including interactions with major agencies.

Qualifications

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
• 7+ years regulatory experience with drug development (US & C region).
• Proven leadership in strategic regulatory planning and cross-functional collaboration.

Responsibilities

• Lead cross-functional GRPT to develop global regulatory strategies.
• Ensure strategic messaging in global dossiers and agency responses.
• Accountable for regulatory risk assessment and mitigation for assigned products.
• Mentor GRPT members and influence regulatory policy with senior management.

Skills

Regulatory leadership

Cross-functional collaboration

Project management

Strategic regulatory planning

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

AbbVie seeks a Director Regulatory Affairs GRL II in Global Regulatory Strategy. The role develops and implements global strategies to secure and maintain market approvals, leads the GRPT, and collaborates with AST and cross-functional teams to mitigate regulatory risks.

You will drive global product strategies across development and lifecycle management, mentor team members, and influence regulatory policy at senior levels, including interactions with major agencies.