Neuroscience: Global Regulatory Strategy Director

AbbVie; Cambridge (MA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Long-term incentives

Comprehensive benefits

Job summary

AbbVie in Cambridge, MA, seeks a Director Regulatory Affairs Global Regulatory Lead (GRL II) for Neuroscience. You will develop global regulatory strategies, lead the GRPT, oversee dossier development, and ensure compliant submissions across US, EU, and other regions.

You will anticipate risks, coordinate labeling strategies, and mentor junior staff while aligning with senior management. You will drive cross-functional collaboration with clinical, pharmacovigilance, and manufacturing teams,

Qualifications

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related field.
• Advanced degree preferred; certification a plus.

Responsibilities

• Interfaces with regulatory teams to lead global strategies and regulatory dossiers.
• Leads cross-functional teams to ensure strategic messaging in global submissions.
• Accountable for meeting corporate goals and regulatory policy for assigned products.
• Leads development of global regulatory product strategies and risk mitigation planning.
• Mentors GRPT members; may have direct reports and contribute to performance management.
• Analyzes regulations and guidance for worldwide regulatory accountability.

Skills

Regulatory strategy

Leadership

Global regulation

Project management

Regulatory submissions

Communication

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

AbbVie in Cambridge, MA, seeks a Director Regulatory Affairs Global Regulatory Lead (GRL II) for Neuroscience. You will develop global regulatory strategies, lead the GRPT, oversee dossier development, and ensure compliant submissions across US, EU, and other regions.

You will anticipate risks, coordinate labeling strategies, and mentor junior staff while aligning with senior management. You will drive cross-functional collaboration with clinical, pharmacovigilance, and manufacturing teams,