Global Regulatory Strategy Director - Lead Cross-Functional RA

BioSpace; Florham Park (NJ); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Health insurance

401(k)

Paid time off

Job summary

AbbVie is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL II) to develop and implement global regulatory strategies ensuring market approvals and lifecycle management for products. This role leads cross-functional teams, interfaces with LRST/AST, and advances regulatory policy while managing risk across the development life cycle.

The position emphasizes leadership in a complex, matrix environment, with strong stakeholder influence and communication skills, and requires

Qualifications

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
• Relevant advanced degree is preferred. Certification a plus.
• 7+ years regulatory experience. Some portion may include experience related to pharmaceutical regulatory work and drug development in US&C region.
• Strong communication and proactive negotiation skills. Experience developing and implementing successful global regulatory strategies.

Responsibilities

• Interfaces with the LRST and AST to lead and support cross-functional company objectives.
• Leads the GRPT to development of global strategies in line with regulations to achieve business objectives for development and marketed products; seeks expert advice when needed.
• Leads cross-functional stakeholders to ensure clear strategic messaging in global regulatory dossiers and responses to Agency requests.
• Accountable for ensuring corporate goals are met; drives regulatory policy and strategy for assigned products.
• Leads preparation of global regulatory product strategies and risk assessment for assigned products; communicates plans to stakeholders.
• Mentions ability to provide coaching for GRPT members and may have direct reports.

Skills

Regulatory leadership

Strategic planning

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

AbbVie is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL II) to develop and implement global regulatory strategies ensuring market approvals and lifecycle management for products. This role leads cross-functional teams, interfaces with LRST/AST, and advances regulatory policy while managing risk across the development life cycle.

The position emphasizes leadership in a complex, matrix environment, with strong stakeholder influence and communication skills, and requires