Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins - Hybrid
AbbVie
August 19, 2026
Remote friendly (North Chicago, IL)
United States
$124,500 - $236,500 USD yearly
Corporate Functions
Responsibilities:
- Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market products or products in development.
- Ensure regulatory strategies in the GRPT are implemented and maintained in line with changing regulatory and business needs.
- Identify and gather data to support filings, responses to inquiries, and registration maintenance to support commercialization in compliance with US and Canada regulatory requirements.
- Own or support regulatory strategy development/execution for product(s) with multiple driver indications within a therapeutic area.
- Serve as FDA Health Authority liaison; coordinate preparation and completion of FDA meeting briefing packages and responses.
- Advise internal stakeholders on Regulatory/FDA issues (e.g., Public Affairs, Clinical Development, Legal, Commercial).
- Independently negotiate and make decisions on cross-functional project issues.
- Prepare and review regulatory submissions; ensure complete and timely responses to health authorities.
- Support regulatory submission and approval; apply regulatory/technical knowledge across therapeutic areas.
- Recommend and implement changes to difficult projects using interpretation of US/Canada regulations, guidances, corporate policies, and management considerations.
- Present pertinent regulatory information to cross-functional areas.
- Operate in compliance with regulations, company policies/procedures, and guidance aligned with regulatory product strategy and the Quality Dossier Program (QDP).
Qualifications:
- Advanced degree (e.g., PharmD, PhD, MS) or Regulatory certification with 5+ years Regulatory, R&D, or equivalent industry experience.
- Preferred: Advanced degree/certifications or direct experience with pharmaceutical regulatory activities.
- Excellent negotiation, problem solving, consensus-building.
- Effective written and oral communication within Regulatory and across the organization.
- Proven skill implementing successful affiliate regulatory strategies (US or Canada experience preferred).
- Experience in complex, matrix environments.
- Experience interfacing with government regulatory agencies.
- Global regulatory experience is a plus.
Benefits (if applicable in posting): Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.
- Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market products or products in development.
- Ensure regulatory strategies in the GRPT are implemented and maintained in line with changing regulatory and business needs.
- Identify and gather data to support filings, responses to inquiries, and registration maintenance to support commercialization in compliance with US and Canada regulatory requirements.
- Own or support regulatory strategy development/execution for product(s) with multiple driver indications within a therapeutic area.
- Serve as FDA Health Authority liaison; coordinate preparation and completion of FDA meeting briefing packages and responses.
- Advise internal stakeholders on Regulatory/FDA issues (e.g., Public Affairs, Clinical Development, Legal, Commercial).
- Independently negotiate and make decisions on cross-functional project issues.
- Prepare and review regulatory submissions; ensure complete and timely responses to health authorities.
- Support regulatory submission and approval; apply regulatory/technical knowledge across therapeutic areas.
- Recommend and implement changes to difficult projects using interpretation of US/Canada regulations, guidances, corporate policies, and management considerations.
- Present pertinent regulatory information to cross-functional areas.
- Operate in compliance with regulations, company policies/procedures, and guidance aligned with regulatory product strategy and the Quality Dossier Program (QDP).
Qualifications:
- Advanced degree (e.g., PharmD, PhD, MS) or Regulatory certification with 5+ years Regulatory, R&D, or equivalent industry experience.
- Preferred: Advanced degree/certifications or direct experience with pharmaceutical regulatory activities.
- Excellent negotiation, problem solving, consensus-building.
- Effective written and oral communication within Regulatory and across the organization.
- Proven skill implementing successful affiliate regulatory strategies (US or Canada experience preferred).
- Experience in complex, matrix environments.
- Experience interfacing with government regulatory agencies.
- Global regulatory experience is a plus.
Benefits (if applicable in posting): Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.