Senior Manager, Regulatory Affairs US & Canada Strategy Lead, Therapeutic Neuroscience - Hybrid
AbbVie
August 25, 2026
Remote friendly (Florham Park, NJ)
United States
$124,500 - $236,500 USD yearly
Corporate Functions
Senior Manager, Regulatory Affairs US & Canada Strategy Lead
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 regulatory and business needs; gather data to support filings, inquiries, and registration maintenance to enable commercialization meeting US/Canada regulatory requirements.
- Serve as Health Authority liaison and interface with FDA for meetings/teleconferences; coordinate FDA meeting briefing packages and responses.
- Advise internal stakeholders (e.g., Public Affairs, Clinical Development, Legal, Commercial) on Regulatory/FDA issues.
- Independently negotiate and make decisions for project-related issues with cross-functional impact.
- Prepare and review regulatory submissions per US/Canada requirements and ensure complete and timely Health Authority responses during review.
- Support regulatory submission and approval process; apply regulatory/technical knowledge across therapeutic areas.
- Recommend and implement changes to difficult projects based on interpretation of US/Canada regulations/guidance and corporate policies.
- Present pertinent regulatory information to cross-functional areas.
- Operate in compliance with regulations, company policies/procedures/guidance, aligned with regulatory product strategy and the Quality Dossier Program (QDP).
- Significant work activity: continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day).
Qualifications:
- Advanced degree (PharmD, PhD, MS) or Regulatory certification with at least 5 years Regulatory, R&D, or equivalent industry experience.
- Preferred: Advanced degree and/or certifications or direct experience with pharmaceutical regulatory activities.
- Excellent negotiation, problem-solving, and consensus-building skills.
- Effective written and oral communication within Regulatory and across 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 (if explicitly stated):
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) to eligible employees; eligibility for long-term incentive programs.
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 regulatory and business needs; gather data to support filings, inquiries, and registration maintenance to enable commercialization meeting US/Canada regulatory requirements.
- Serve as Health Authority liaison and interface with FDA for meetings/teleconferences; coordinate FDA meeting briefing packages and responses.
- Advise internal stakeholders (e.g., Public Affairs, Clinical Development, Legal, Commercial) on Regulatory/FDA issues.
- Independently negotiate and make decisions for project-related issues with cross-functional impact.
- Prepare and review regulatory submissions per US/Canada requirements and ensure complete and timely Health Authority responses during review.
- Support regulatory submission and approval process; apply regulatory/technical knowledge across therapeutic areas.
- Recommend and implement changes to difficult projects based on interpretation of US/Canada regulations/guidance and corporate policies.
- Present pertinent regulatory information to cross-functional areas.
- Operate in compliance with regulations, company policies/procedures/guidance, aligned with regulatory product strategy and the Quality Dossier Program (QDP).
- Significant work activity: continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day).
Qualifications:
- Advanced degree (PharmD, PhD, MS) or Regulatory certification with at least 5 years Regulatory, R&D, or equivalent industry experience.
- Preferred: Advanced degree and/or certifications or direct experience with pharmaceutical regulatory activities.
- Excellent negotiation, problem-solving, and consensus-building skills.
- Effective written and oral communication within Regulatory and across 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 (if explicitly stated):
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) to eligible employees; eligibility for long-term incentive programs.