Director, RA Global Regulatory Strategy
AbbVie
June 30, 2026
Remote friendly (North Chicago, IL)
United States
$182,000 - $346,000 USD yearly
Corporate Functions
Job Description
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 products in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). May lead the Labeling Regulatory Strategy Team (LRST). Acts as primary regulatory interface with AST and supporting teams; anticipates/mitigates regulatory risks; ensures compliance with global regulatory requirements; manages compounds through development and lifecycle; develops and implements acceleration strategies; manages projects and regulatory strategy documentation.
Responsibilities
- Interface with LRST and AST; lead GRPT to develop global strategies aligned with applicable regulations.
- Lead cross-functional stakeholders to ensure clear strategic messaging in regulatory dossiers and responses to Agency requests.
- Drive regulatory policy and strategy; accountable for corporate goals.
- Lead global regulatory product strategy development, including risk assessment/mitigation planning and stakeholder communication.
- Independently operate under direction; expand TA knowledge; coach/mentor; may manage direct reports.
- Analyze regulations/guidance and provide worldwide accountability for assigned products.
- Maintain regulatory record-keeping policies; develop/implement RA department procedures as needed.
- Ensure alignment with Senior Management; present recommendations to executive management; inform stakeholders of issues/labeling outcomes/risks and mitigations.
- Make decisions on work processes/operational plans; lead initiatives in professional associations.
- Follow budget allocations; manage resourcing; chair/sponsor key GRS initiatives and present outcomes.
Qualifications
Required
- Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- 7+ years regulatory experience; drug development experience in US&C.
- 5+ years strategic leadership with strong project management.
- Experience in complex matrix environments; influence cross-functional teams.
- Strong communication and proactive negotiation.
- Experience developing and implementing global regulatory strategies.
Preferred
- Relevant advanced degree; certification a plus.
- 10+ years pharmaceutical regulatory activities; lead regulatory product strategist in 2+ major regions (e.g., EU, Japan) in addition to US.
Benefits (if applicable)
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k).
- Eligible for short-term incentive programs.
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 products in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). May lead the Labeling Regulatory Strategy Team (LRST). Acts as primary regulatory interface with AST and supporting teams; anticipates/mitigates regulatory risks; ensures compliance with global regulatory requirements; manages compounds through development and lifecycle; develops and implements acceleration strategies; manages projects and regulatory strategy documentation.
Responsibilities
- Interface with LRST and AST; lead GRPT to develop global strategies aligned with applicable regulations.
- Lead cross-functional stakeholders to ensure clear strategic messaging in regulatory dossiers and responses to Agency requests.
- Drive regulatory policy and strategy; accountable for corporate goals.
- Lead global regulatory product strategy development, including risk assessment/mitigation planning and stakeholder communication.
- Independently operate under direction; expand TA knowledge; coach/mentor; may manage direct reports.
- Analyze regulations/guidance and provide worldwide accountability for assigned products.
- Maintain regulatory record-keeping policies; develop/implement RA department procedures as needed.
- Ensure alignment with Senior Management; present recommendations to executive management; inform stakeholders of issues/labeling outcomes/risks and mitigations.
- Make decisions on work processes/operational plans; lead initiatives in professional associations.
- Follow budget allocations; manage resourcing; chair/sponsor key GRS initiatives and present outcomes.
Qualifications
Required
- Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- 7+ years regulatory experience; drug development experience in US&C.
- 5+ years strategic leadership with strong project management.
- Experience in complex matrix environments; influence cross-functional teams.
- Strong communication and proactive negotiation.
- Experience developing and implementing global regulatory strategies.
Preferred
- Relevant advanced degree; certification a plus.
- 10+ years pharmaceutical regulatory activities; lead regulatory product strategist in 2+ major regions (e.g., EU, Japan) in addition to US.
Benefits (if applicable)
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k).
- Eligible for short-term incentive programs.