Director, RA Global Regulatory Strategy
AbbVie
August 13, 2026
Remote friendly (Waltham, MA)
United States
$182,000 - $346,000 USD yearly
Operations
Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy
Responsibilities:
- Develop and implement global regulatory strategies to secure and maintain market approval for products in the assigned therapeutic area.
- Lead the Global Regulatory Product Team (GRPT); expand therapeutic area knowledge and ensure strategic messaging/content of global regulatory dossiers.
- Interface as primary regulatory contact with AST and supporting teams; proactively anticipate and mitigate regulatory risks.
- Ensure compliance with global regulatory requirements across all product development phases and throughout the product lifecycle.
- May lead the Labeling Regulatory Strategy Team (LRST).
- Lead preparation and maintenance of global regulatory product strategies, including risk assessment and mitigation plans.
- Lead cross-functional stakeholders to ensure clear strategic messaging in dossiers and agency responses.
- Influence development of regulations/guidance; analyze legislation/regulations and provide organization-wide input with accountability for assigned products.
- Develop and implement regulatory record-keeping policies/procedures within RA as needed; ensure direct reports follow requirements.
- Present regulatory assessments and recommendations to executive management; proactively inform AST and cross-functional leadership on issues, labeling outcomes, approvals, and mitigations.
- Make decisions on work processes/operational plans; manage resourcing and chair/sponsor key initiatives.
Qualifications:
- Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- Preferred: Relevant advanced degree; certification a plus.
- 7+ years regulatory experience; includes drug development experience in US & C.
- 5+ years in a strategic leadership role with strong project management.
- Experience in complex matrix environments; influencing cross-functional teams.
- Strong communication and proactive negotiation skills; experience developing and implementing global regulatory strategies.
- Preferred: 10+ years in pharmaceutical regulatory activities; lead regulatory product strategist in two+ major regions (e.g., EU/Japan) in addition to US.
Benefits:
- Comprehensive package including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.
Application instructions:
- None stated.
Responsibilities:
- Develop and implement global regulatory strategies to secure and maintain market approval for products in the assigned therapeutic area.
- Lead the Global Regulatory Product Team (GRPT); expand therapeutic area knowledge and ensure strategic messaging/content of global regulatory dossiers.
- Interface as primary regulatory contact with AST and supporting teams; proactively anticipate and mitigate regulatory risks.
- Ensure compliance with global regulatory requirements across all product development phases and throughout the product lifecycle.
- May lead the Labeling Regulatory Strategy Team (LRST).
- Lead preparation and maintenance of global regulatory product strategies, including risk assessment and mitigation plans.
- Lead cross-functional stakeholders to ensure clear strategic messaging in dossiers and agency responses.
- Influence development of regulations/guidance; analyze legislation/regulations and provide organization-wide input with accountability for assigned products.
- Develop and implement regulatory record-keeping policies/procedures within RA as needed; ensure direct reports follow requirements.
- Present regulatory assessments and recommendations to executive management; proactively inform AST and cross-functional leadership on issues, labeling outcomes, approvals, and mitigations.
- Make decisions on work processes/operational plans; manage resourcing and chair/sponsor key initiatives.
Qualifications:
- Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- Preferred: Relevant advanced degree; certification a plus.
- 7+ years regulatory experience; includes drug development experience in US & C.
- 5+ years in a strategic leadership role with strong project management.
- Experience in complex matrix environments; influencing cross-functional teams.
- Strong communication and proactive negotiation skills; experience developing and implementing global regulatory strategies.
- Preferred: 10+ years in pharmaceutical regulatory activities; lead regulatory product strategist in two+ major regions (e.g., EU/Japan) in addition to US.
Benefits:
- Comprehensive package including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.
Application instructions:
- None stated.