Director, RA Global Regulatory Strategy
AbbVie
June 26, 2026
Remote friendly (North Chicago, IL)
United States
$182,000 - $346,000 USD yearly
Corporate Functions
Job Description
The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, develops and implements global regulatory strategies to secure and maintain market approval for products in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Ensures strategic messaging and content of global regulatory dossiers; may lead the Labeling Regulatory Strategy Team (LRST). Serves as primary regulatory interface with AST and supporting teams. Proactively anticipates/mitigates regulatory risks, ensures compliance, and manages compounds through development and the product life cycle. Leads acceleration strategies and manages regulatory strategy projects and documentation.
Responsibilities
- Interface with LRST and AST; lead GRPT to create global regulatory strategies aligned with regulations and business objectives.
- Lead cross-functional teams to ensure clear strategic messaging in dossiers and responses to regulatory agencies.
- Own regulatory policy/strategy and ensure corporate goals are met.
- Prepare and maintain global regulatory product strategies, including risk assessment/mitigation plans and stakeholder communications.
- Independently lead regulatory/product initiatives; coach/mentor GRPT; may manage direct reports.
- Analyze legislation/regulations/guidance; provide worldwide accountability and regulatory recommendations.
- Manage regulatory record-keeping; develop RA policies/procedures as needed.
- Align strategies with senior management; present recommendations/assessments; represent regulatory position in Joint Governance.
- Make decisions on operational plans; participate in professional associations.
- Monitor budget/resourcing; chair/sponsor key GRS initiatives and report outcomes.
Qualifications
- Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- Preferred: advanced degree; certification a plus.
- Required: 7+ years regulatory experience; US&C drug development experience; 5+ years in strategic leadership with strong project management; experience in complex matrix environments; interface with government regulators; strong communication and proactive negotiation; experience developing/implementing global regulatory strategies.
- Preferred: 10+ years pharmaceutical regulatory experience; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan) plus US; strong global drug development foundation and business acumen.
Benefits (if applicable/eligible)
- Paid time off; medical/dental/vision insurance; 401(k); long-term incentive program eligibility.
The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, develops and implements global regulatory strategies to secure and maintain market approval for products in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Ensures strategic messaging and content of global regulatory dossiers; may lead the Labeling Regulatory Strategy Team (LRST). Serves as primary regulatory interface with AST and supporting teams. Proactively anticipates/mitigates regulatory risks, ensures compliance, and manages compounds through development and the product life cycle. Leads acceleration strategies and manages regulatory strategy projects and documentation.
Responsibilities
- Interface with LRST and AST; lead GRPT to create global regulatory strategies aligned with regulations and business objectives.
- Lead cross-functional teams to ensure clear strategic messaging in dossiers and responses to regulatory agencies.
- Own regulatory policy/strategy and ensure corporate goals are met.
- Prepare and maintain global regulatory product strategies, including risk assessment/mitigation plans and stakeholder communications.
- Independently lead regulatory/product initiatives; coach/mentor GRPT; may manage direct reports.
- Analyze legislation/regulations/guidance; provide worldwide accountability and regulatory recommendations.
- Manage regulatory record-keeping; develop RA policies/procedures as needed.
- Align strategies with senior management; present recommendations/assessments; represent regulatory position in Joint Governance.
- Make decisions on operational plans; participate in professional associations.
- Monitor budget/resourcing; chair/sponsor key GRS initiatives and report outcomes.
Qualifications
- Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- Preferred: advanced degree; certification a plus.
- Required: 7+ years regulatory experience; US&C drug development experience; 5+ years in strategic leadership with strong project management; experience in complex matrix environments; interface with government regulators; strong communication and proactive negotiation; experience developing/implementing global regulatory strategies.
- Preferred: 10+ years pharmaceutical regulatory experience; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan) plus US; strong global drug development foundation and business acumen.
Benefits (if applicable/eligible)
- Paid time off; medical/dental/vision insurance; 401(k); long-term incentive program eligibility.