Senior Manager, Regulatory Affairs US & Canada Strategy Lead, Therapeutic Neuroscience - Hybrid
AbbVie
August 25, 2026
Remote friendly (Irvine, CA)
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 defined within 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 for US and Canada commercialization.
- Serve as Health Authority (HA) liaison; interface with FDA for meetings/teleconferences; coordinate FDA briefing packages and responses.
- Advise internal customers (e.g., Public Affairs, Clinical Development, Legal, Commercial) on Regulatory/FDA issues.
- Independently handle negotiation and decision-making for cross-functional project issues.
- Assist in training junior staff.
- Prepare and review regulatory submissions to meet US/Canada requirements; ensure complete and timely Health Authority responses.
- Support regulatory submission and approval process; apply regulatory/technical knowledge across therapeutic areas.
- Recommend and implement changes to projects using expertise in US/Canada regulations, guidance, and corporate policies.
- Present pertinent regulatory information to cross-functional areas.
- Operate in compliance with regulations, company policies/procedures, and the Quality Dossier Program (QDP).
Qualifications:
- Advanced degree (PharmD, PhD, MS) or Regulatory certification; minimum 5 years Regulatory, R&D, or equivalent industry experience.
- Preferred: advanced degree/certifications or direct experience with pharmaceutical regulatory activities.
- Excellent negotiation, problem solving, and consensus-building skills.
- Effective written and oral communication across and within the organization.
- Proven skill implementing 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:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible for long-term incentive programs.
Application instructions:
- None provided.
- Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market products or products in development.
- Ensure regulatory strategies defined within 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 for US and Canada commercialization.
- Serve as Health Authority (HA) liaison; interface with FDA for meetings/teleconferences; coordinate FDA briefing packages and responses.
- Advise internal customers (e.g., Public Affairs, Clinical Development, Legal, Commercial) on Regulatory/FDA issues.
- Independently handle negotiation and decision-making for cross-functional project issues.
- Assist in training junior staff.
- Prepare and review regulatory submissions to meet US/Canada requirements; ensure complete and timely Health Authority responses.
- Support regulatory submission and approval process; apply regulatory/technical knowledge across therapeutic areas.
- Recommend and implement changes to projects using expertise in US/Canada regulations, guidance, and corporate policies.
- Present pertinent regulatory information to cross-functional areas.
- Operate in compliance with regulations, company policies/procedures, and the Quality Dossier Program (QDP).
Qualifications:
- Advanced degree (PharmD, PhD, MS) or Regulatory certification; minimum 5 years Regulatory, R&D, or equivalent industry experience.
- Preferred: advanced degree/certifications or direct experience with pharmaceutical regulatory activities.
- Excellent negotiation, problem solving, and consensus-building skills.
- Effective written and oral communication across and within the organization.
- Proven skill implementing 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:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible for long-term incentive programs.
Application instructions:
- None provided.