Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins - Hybrid
AbbVie
August 19, 2026
Remote friendly (Irvine, CA)
United States
$124,500 - $236,500 USD yearly
Corporate Functions
The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market products or those in development. Assures regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs.
Responsibilities:
- Support the development and execution of the regulatory strategy for product(s) within a Therapeutic Area (including multiple driver indications).
- Serve as Health Authority (HA) liaison; interface with FDA for meetings/teleconferences; coordinate FDA meeting briefing packages and responses.
- Advise internal customers on Regulatory/FDA issues (e.g., Public Affairs, Clinical Development, Legal, Commercial).
- Independently negotiate and make decisions on project issues with cross-functional impact.
- May assist in training junior staff.
- Prepare and review regulatory submissions; ensure complete, timely Health Authority responses during application review.
- Support the regulatory submission and approval process.
- Recommend and implement changes to difficult projects based on US/Canada regulations, guidances, and corporate policies.
- Present pertinent regulatory information to cross-functional areas.
- Operate in compliance with regulations and company guidance in alignment 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 hr day) is required.
Qualifications:
- Advanced degree (e.g., PharmD, PhD, MS) or Regulatory certification with 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 Regulatory.
- 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.
Responsibilities:
- Support the development and execution of the regulatory strategy for product(s) within a Therapeutic Area (including multiple driver indications).
- Serve as Health Authority (HA) liaison; interface with FDA for meetings/teleconferences; coordinate FDA meeting briefing packages and responses.
- Advise internal customers on Regulatory/FDA issues (e.g., Public Affairs, Clinical Development, Legal, Commercial).
- Independently negotiate and make decisions on project issues with cross-functional impact.
- May assist in training junior staff.
- Prepare and review regulatory submissions; ensure complete, timely Health Authority responses during application review.
- Support the regulatory submission and approval process.
- Recommend and implement changes to difficult projects based on US/Canada regulations, guidances, and corporate policies.
- Present pertinent regulatory information to cross-functional areas.
- Operate in compliance with regulations and company guidance in alignment 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 hr day) is required.
Qualifications:
- Advanced degree (e.g., PharmD, PhD, MS) or Regulatory certification with 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 Regulatory.
- 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.