Director, RA Global Regulatory Strategy
AbbVie
June 25, 2026
Remote friendly (North Chicago, IL)
United States
$182,000 - $346,000 USD yearly
Corporate Functions
The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the product life cycle. Develops and implements acceleration strategies; manages projects and documentation of regulatory strategies.
Responsibilities:
- Interface with LRST and AST; lead GRPT development of global regulatory strategies to meet business objectives.
- Lead cross-functional stakeholders to ensure clear strategic messaging in global regulatory dossiers and agency responses.
- Lead preparation/maintenance of risk assessment and mitigation strategies; communicate plans to stakeholders.
- Influence development of regulations and guidance; analyze legislation/regulations and provide org-wide accountability.
- Ensure alignment of global regulatory strategies with senior management; present recommendations and assess impact on global programs.
- Make decisions on work processes/operational plans to meet program objectives; manage resourcing and key initiatives.
Qualifications:
Required Education: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
Preferred Education: Relevant advanced degree; certification a plus.
Required Experience: 7+ years regulatory experience; 5+ years in strategic leadership; drug development experience in US & C region; experience interfacing with major government regulators; strong communication and negotiation; global regulatory strategy development/implementation.
Preferred Experience: 10+ years pharmaceutical regulatory activities; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan) in addition to US; strong global drug development and business acumen.
Benefits (if applicable): Paid time off; medical/dental/vision insurance; 401(k); eligible for long-term incentive programs.
Responsibilities:
- Interface with LRST and AST; lead GRPT development of global regulatory strategies to meet business objectives.
- Lead cross-functional stakeholders to ensure clear strategic messaging in global regulatory dossiers and agency responses.
- Lead preparation/maintenance of risk assessment and mitigation strategies; communicate plans to stakeholders.
- Influence development of regulations and guidance; analyze legislation/regulations and provide org-wide accountability.
- Ensure alignment of global regulatory strategies with senior management; present recommendations and assess impact on global programs.
- Make decisions on work processes/operational plans to meet program objectives; manage resourcing and key initiatives.
Qualifications:
Required Education: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
Preferred Education: Relevant advanced degree; certification a plus.
Required Experience: 7+ years regulatory experience; 5+ years in strategic leadership; drug development experience in US & C region; experience interfacing with major government regulators; strong communication and negotiation; global regulatory strategy development/implementation.
Preferred Experience: 10+ years pharmaceutical regulatory activities; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan) in addition to US; strong global drug development and business acumen.
Benefits (if applicable): Paid time off; medical/dental/vision insurance; 401(k); eligible for long-term incentive programs.