Senior Manager, Regulatory Affairs US & Canada Strategy Lead, Therapeutic Neuroscience - Hybrid
AbbVie
August 25, 2026
Remote friendly (Cambridge, MA)
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 or in-development products.
- Ensure regulatory strategies in the GRPT are implemented and maintained aligned with changing regulatory and business needs.
- Identify and gather data to support filings, responses to inquiries, and registration maintenance for commercialization in line with US and Canada regulatory requirements.
- Serve as Health Authority (HA) liaison; interface with FDA for meetings/teleconferences and coordinate FDA briefing packages and responses.
- Advise internal customers (e.g., Public Affairs, Clinical Development, Legal, Commercial) on Regulatory/FDA issues.
- Independently negotiate and make project decisions with cross-functional impact.
- Prepare and review regulatory submissions; ensure complete and timely responses during application 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, guidances, and corporate policies.
- 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).
- Significant Work Activity: Continuous sitting for prolonged periods (>2 consecutive hours in an 8-hr day) required.
Qualifications:
- Advanced degree (e.g., 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 and problem-solving skills; builds consensus.
- Effective written and oral communication across Regulatory and the organization.
- Proven skill implementing successful affiliate regulatory strategies (US or Canada experience preferred).
- Experience in a complex, matrix environment.
- Experience interfacing with government regulatory agencies.
- Global regulatory experience is a plus.
Responsibilities:
- Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market or in-development products.
- Ensure regulatory strategies in the GRPT are implemented and maintained aligned with changing regulatory and business needs.
- Identify and gather data to support filings, responses to inquiries, and registration maintenance for commercialization in line with US and Canada regulatory requirements.
- Serve as Health Authority (HA) liaison; interface with FDA for meetings/teleconferences and coordinate FDA briefing packages and responses.
- Advise internal customers (e.g., Public Affairs, Clinical Development, Legal, Commercial) on Regulatory/FDA issues.
- Independently negotiate and make project decisions with cross-functional impact.
- Prepare and review regulatory submissions; ensure complete and timely responses during application 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, guidances, and corporate policies.
- 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).
- Significant Work Activity: Continuous sitting for prolonged periods (>2 consecutive hours in an 8-hr day) required.
Qualifications:
- Advanced degree (e.g., 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 and problem-solving skills; builds consensus.
- Effective written and oral communication across Regulatory and the organization.
- Proven skill implementing successful affiliate regulatory strategies (US or Canada experience preferred).
- Experience in a complex, matrix environment.
- Experience interfacing with government regulatory agencies.
- Global regulatory experience is a plus.