Director, Global Regulatory Strategy & Lifecycle

Regulatory Jobs; Cambridge (MA); On-site; USD 250,000 - 350,000; Full time

Job summary

AbbVie seeks a Director Regulatory Affairs Global Regulatory Lead to develop and implement global strategies ensuring market approvals for products in assigned therapeutic areas. Leads the GRPT, interfaces with LRST/AST, and guides risk assessment and regulatory messaging globally.

Requires 7+ years in regulatory roles, 5+ years in leadership, and strong communication in a complex matrix environment. Advanced degree is a plus; travel may be required.

Qualifications

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
• 7+ years regulatory experience. Some portion may include experience related to pharmaceutical regulatory work.
• 5+ years in a strategic leadership role with strong project management skills.
• Experience interfacing with major government regulatory bodies.

Responsibilities

• Lead the Global Regulatory Product Team (GRPT) to develop global regulatory strategies.
• Interface with LRST and AST to ensure regulatory messaging and content align with regulations.
• Oversee preparation and maintenance of global regulatory product strategies and risk mitigation plans.
• Provide coaching and leadership within the RA team and manage cross-functional collaboration.

Skills

Regulatory leadership

Strategic planning

Project management

Cross-functional influence

Communication skills

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

AbbVie seeks a Director Regulatory Affairs Global Regulatory Lead to develop and implement global strategies ensuring market approvals for products in assigned therapeutic areas. Leads the GRPT, interfaces with LRST/AST, and guides risk assessment and regulatory messaging globally.

Requires 7+ years in regulatory roles, 5+ years in leadership, and strong communication in a complex matrix environment. Advanced degree is a plus; travel may be required.