Global Regulatory Strategy Director – Neuroscience

SmartRecruiters, Inc.; Cambridge (MA); On-site; USD 182,000 - 346,000; Full time

Benefits offered by this job

Long-term incentive programs

Comprehensive benefits

Job summary

AbbVie seeks a Director Regulatory Affairs Global Regulatory Lead (GRL II) to develop and implement global strategies securing and maintaining market approval for products in Neuroscience. Leads the GRPT, expands TA knowledge, and ensures strategic content of regulatory dossiers.

May mentor GRPT members and drive risk assessment and mitigation planning across development life cycles. Role interfaces with LRST and AST, aligns regulatory strategies with senior management, and drives

Qualifications

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
• 7+ years regulatory experience; US & C region drug development exposure.
• 5+ years in strategic leadership with cross-functional teams.
• Strong communication and negotiation skills; ability to influence across matrixed teams.
• 10+ years in pharmaceutical regulatory activities; lead strategist in two major regions.

Responsibilities

• Lead global regulatory strategies for development and marketed products.
• Guide GRPT and cross-functional teams; ensure strategic messaging in dossiers.
• Mentor GRPT members and manage possible direct reports.
• Influence regulatory policy and analyze legislation globally.
• Present regulatory assessments to executive management; manage budgets and timelines.

Skills

Regulatory leadership

Global regulatory strategy

Cross-functional leadership

Project management

Communication

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

AbbVie seeks a Director Regulatory Affairs Global Regulatory Lead (GRL II) to develop and implement global strategies securing and maintaining market approval for products in Neuroscience. Leads the GRPT, expands TA knowledge, and ensures strategic content of regulatory dossiers.

May mentor GRPT members and drive risk assessment and mitigation planning across development life cycles. Role interfaces with LRST and AST, aligns regulatory strategies with senior management, and drives