Senior Regulatory Strategy Lead, US & Canada

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

Job summary

AbbVie in the United States seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead to develop and implement regulatory strategies for on‑market and development programs. You will coordinate with Health Authorities, notably the FDA, and cross‑functional teams to prepare filings and respond to inquiries to enable product commercialization.

Requires an advanced degree or regulatory certification with at least 5 years of regulatory/R&D experience, excellent negotiation and

Qualifications

• Advanced degree or regulatory certification with minimum 5 years in regulatory, R&D, or related experience.
• Strong negotiation, problem-solving, and consensus-building abilities.
• Effective written and oral communication within Regulatory and cross-functional teams.
• Experience with affiliate regulatory strategies and US/Canada regulatory activities.
• Experience interfacing with government regulatory agencies and working in a complex matrix environment.

Responsibilities

• Develop and execute regulatory strategy for US & Canada.
• Serve as Health Authority liaison and coordinate FDA meetings.
• Advise internal stakeholders on regulatory/FDA issues.
• Negotiate and decide on project issues with cross-functional impact.
• Contribute to training junior staff.
• Prepare and review regulatory submissions for US/Canada.
• Support regulatory submission and approval processes.
• Apply regulatory knowledge to guidelines and policies.
• Present regulatory information to cross-functional areas.
• Ensure compliance with regulations and QDP alignment.
• Significant Work Activities: Long sitting for prolonged periods.

Skills

Regulatory strategy

Negotiation

Communication

Cross-functional collaboration

Problem solving

FDA liaison

Education

Advanced degree in pharma/regulatory science

Regulatory certification

Job description

AbbVie in the United States seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead to develop and implement regulatory strategies for on‑market and development programs. You will coordinate with Health Authorities, notably the FDA, and cross‑functional teams to prepare filings and respond to inquiries to enable product commercialization.

Requires an advanced degree or regulatory certification with at least 5 years of regulatory/R&D experience, excellent negotiation and