Strategic Regulatory Affairs Leader, US & Canada

PowerToFly; North Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie seeks a Regulatory Strategy Lead for US and Canada to shape lifecycle planning, manage health authority interactions, and coordinate submissions across a complex, matrixed organization.

You will collaborate with diverse teams to ensure compliant, timely regulatory outcomes while advancing strategic initiatives in immunology, oncology and neuroscience. This role emphasizes leadership, communication, and in-depth regulatory expertise.

Qualifications

• Advanced degree or Regulatory certification with minimum 7 years Regulatory, R&D, or equivalent experience.
• Excellent written and oral communication within Regulatory and across the organization.
• Extensive experience interfacing with government Agencies and Health Authority personnel.
• Able to deliver challenging messages effectively without compromising relationships.
• Experience working in a complex and matrixed environment.
• Demonstrated success in negotiation, strategic thinking, and credibility within the organization.
• Proven skill at implementing affiliate regulatory strategies (US or Canada) experience preferred.
• US Class III device experience and familiarity with manufacturing processes/change control assessments preferred.
• Demonstrated forward-thinking strategic experience to accelerate programs or regulatory precedence.

Responsibilities

• Lead development and execution of US/Canada regulatory strategies (RSTP) for on‑market products or development programs.
• Coordinate lifecycle regulatory activities including product changes, post‑approval commitments, and health authority information requests.
• Interface with FDA and other health authorities; prepare meetings, briefing packages and responses.
• Advise internal teams on regulatory communications and strategy across Commercial, Legal, Clinical and Public Affairs.
• Operate independently with mentorship as needed and provide guidance on regulatory planning and decision making.
• Support training and mentoring of junior staff in regulatory processes and submissions.
• Coordinate and supervise preparation/review of regulatory submissions for US/Canada, ensuring compliance with guidelines.
• Maintain current knowledge of US/Canada regulations and guidance to align with corporate goals.
• Present regulatory information to cross-functional teams and ensure alignment with QDP and GRPT directives.
• Ensure timely and complete responses to Health Authorities during reviews and maintain robust documentation.

Skills

Regulatory communication

Stakeholder management

Negotiation

Strategic thinking

Regulatory knowledge

Cross-functional collaboration

Education

Advanced degree (PharmD/PhD/MS) or Regulatory certification

Job description

AbbVie seeks a Regulatory Strategy Lead for US and Canada to shape lifecycle planning, manage health authority interactions, and coordinate submissions across a complex, matrixed organization.

You will collaborate with diverse teams to ensure compliant, timely regulatory outcomes while advancing strategic initiatives in immunology, oncology and neuroscience. This role emphasizes leadership, communication, and in-depth regulatory expertise.