US & Canada Regulatory Strategy Lead – Neuroscience

AbbVie; Florham Park (NJ); Hybrid; USD 125,000 - 237,000; Full time

Benefits offered by this job

Comprehensive benefits

401(k) plan

Job summary

AbbVie seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead, Therapeutic Neuroscience, to drive regulatory strategy and tactical planning for US and Canada across on-market and development products. The role integrates with global teams to ensure timely filings and approvals, with a hybrid work arrangement.

The position requires an advanced degree or regulatory certification with 5+ years in regulatory/R&D, strong negotiation and communication skills, and proven experience

Qualifications

• Advanced degree (PharmD/PhD/MS) or regulatory certification with at least 5 years in regulatory/R&D.
• Experience leading US and/or Canada regulatory strategy and submissions.
• Strong negotiation and cross-functional communication skills.

Responsibilities

• Serve as Health Authority liaison and interface with FDA for meetings and briefing packages.
• Lead development and implementation of regulatory strategy for US & Canada in assigned products.
• Prepare and review regulatory submissions ensuring alignment with US/Canada requirements.
• Provide regulatory guidance to cross-functional teams including Clinical Development, Legal and Commercial.
• Support regulatory submissions and approvals; apply regulatory knowledge across therapeutic areas.
• Ensure compliance with regulatory product strategy and QDP.

Skills

Regulatory strategy

Stakeholder communication

Regulatory submissions

Negotiation

FDA liaison

Education

Advanced degree or regulatory certification

Job description

AbbVie seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead, Therapeutic Neuroscience, to drive regulatory strategy and tactical planning for US and Canada across on-market and development products. The role integrates with global teams to ensure timely filings and approvals, with a hybrid work arrangement.

The position requires an advanced degree or regulatory certification with 5+ years in regulatory/R&D, strong negotiation and communication skills, and proven experience