Regulatory Strategy Lead — US & Canada

BioSpace; Cambridge (MA); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Job summary

AbbVie in the United States is seeking a Senior Manager Regulatory Affairs to lead regulatory strategy for US and Canada, ensuring timely submissions and compliance across therapeutic areas. The role requires collaboration across Regulatory, Clinical Development, Legal, and Commercial teams.

The position supports a hybrid work schedule with in-office and remote days and will operate from major US sites including Cambridge, MA, Lake County IL, Florham Park NJ, or Irvine CA as needed.

Qualifications

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or related industry field.
• Minimum of 6 years in regulatory affairs, R&D, or related pharmaceutical field, including 2–3 years of regulatory activities.
• Demonstrates negotiation, problem solving and consensus-building; effective written and oral communication.
• Experience in US and Canada regulatory strategies and interfacing with government agencies.

Responsibilities

• Develop and implement US/Canada regulatory strategic and tactical planning (RSTP) for products.
• Serve as HA liaison and interface with FDA for meetings and briefing packages.
• Prepare and review regulatory submissions and responses during reviews by Health Authorities.
• Support regulatory submission/approval process and apply knowledge of regulations, guidances, and policies.

Skills

Regulatory strategy

FDA liaison

Regulatory submissions

Cross-functional collaboration

US/Canada regulatory knowledge

Education

Bachelor’s degree in pharmacy/biology/chemistry/pharmacology

Advanced degree or certifications (plus)

Job description

AbbVie in the United States is seeking a Senior Manager Regulatory Affairs to lead regulatory strategy for US and Canada, ensuring timely submissions and compliance across therapeutic areas. The role requires collaboration across Regulatory, Clinical Development, Legal, and Commercial teams.

The position supports a hybrid work schedule with in-office and remote days and will operate from major US sites including Cambridge, MA, Lake County IL, Florham Park NJ, or Irvine CA as needed.