Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins - Hybrid
AbbVie
August 25, 2026
Remote friendly (Cambridge, MA)
United States
$124,500 - $236,500 USD yearly
Corporate Functions
The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins is responsible for development and implementation of US/Canada regulatory strategic and tactical planning (RSTP) for assigned on-market or in-development products. Ensures GRPT regulatory strategies are implemented and maintained in line with changing regulatory and business needs.
Responsibilities:
- Own regulatory strategy development/execution for product(s) within a Therapeutic Area; moderate impact on business activities/operations.
- Serve as Health Authority (HA) liaison; interface with FDA for meetings/teleconferences; coordinate FDA briefing packages and responses.
- Advise internal stakeholders (Public Affairs, Clinical Development, Legal, Commercial) on Regulatory/FDA issues.
- Independently negotiate and make cross-functional, project-related decisions.
- May assist in training junior staff.
- Prepare and review regulatory submissions; 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 complex projects using accurate interpretation of US/Canada regulations/guidances and corporate policies.
- Present relevant regulatory information to cross-functional teams.
- Operate in compliance with regulations, company policies, procedures, and guidance aligned with QDP.
Significant Work Activities: Continuous sitting for prolonged periods (>2 consecutive hours in an 8-hr day).
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 pharmaceutical regulatory experience.
- Excellent negotiation, problem solving, consensus building.
- Effective written and oral communication across and within Regulatory.
- Proven skill implementing affiliate regulatory strategies (US/Canada preferred).
- Experience in complex, matrix environments.
- Experience interfacing with government regulatory agencies.
- Global regulatory experience is a plus.
Benefits (explicitly stated): paid time off (vacation/holidays/sick), medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.
Responsibilities:
- Own regulatory strategy development/execution for product(s) within a Therapeutic Area; moderate impact on business activities/operations.
- Serve as Health Authority (HA) liaison; interface with FDA for meetings/teleconferences; coordinate FDA briefing packages and responses.
- Advise internal stakeholders (Public Affairs, Clinical Development, Legal, Commercial) on Regulatory/FDA issues.
- Independently negotiate and make cross-functional, project-related decisions.
- May assist in training junior staff.
- Prepare and review regulatory submissions; 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 complex projects using accurate interpretation of US/Canada regulations/guidances and corporate policies.
- Present relevant regulatory information to cross-functional teams.
- Operate in compliance with regulations, company policies, procedures, and guidance aligned with QDP.
Significant Work Activities: Continuous sitting for prolonged periods (>2 consecutive hours in an 8-hr day).
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 pharmaceutical regulatory experience.
- Excellent negotiation, problem solving, consensus building.
- Effective written and oral communication across and within Regulatory.
- Proven skill implementing affiliate regulatory strategies (US/Canada preferred).
- Experience in complex, matrix environments.
- Experience interfacing with government regulatory agencies.
- Global regulatory experience is a plus.
Benefits (explicitly stated): paid time off (vacation/holidays/sick), medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.