Senior Manager, Regulatory Affairs

Health Marketing; Deerfield (IL); On-site; USD 150,000 - 210,000; Full time

Job summary

Health Marketing in Deerfield, IL is seeking a Senior Manager, Regulatory Strategy to lead U.S. and global regulatory efforts for innovative neuroscience therapies. You will drive lifecycle planning, ensure FDA/ICH compliance, and guide submission strategies across INDs, NDAs, and sNDAs.

The role requires strong leadership, risk assessment, and an ability to influence portfolio decisions while partnering with R&D, clinical, and commercial teams.

Qualifications

• Strong expertise in regulatory strategy, planning, and lifecycle compliance.
• Proven ability to lead regulatory submissions and agency engagement.
• Advanced risk assessment and decision-influencing skills.
• Excellent cross-functional collaboration and communication.
• Deep understanding of FDA/ICH expectations for innovative therapies.

Responsibilities

• Develop and execute regulatory planning across the product lifecycle, from development through post-approval.
• Ensure compliance with FDA and ICH requirements and alignment with corporate objectives.
• Guide regulatory submissions including INDs, NDAs, and sNDAs.
• Lead and manage interactions with regulatory agencies.
• Assess regulatory risk and provide strategic guidance to influence portfolio decisions.
• Partner cross-functionally to support patient-focused development goals.

Skills

Regulatory strategy

Lifecycle compliance

Regulatory submissions

Cross-functional collaboration

FDA/ICH knowledge

Job description

Senior Manager, Regulatory Strategy

to lead U.S. and global regulatory strategy for innovative neuroscience therapies.

Key Responsibilities

• Develop and execute regulatory planning across the product lifecycle, from early development through post-approval.
• Ensure compliance with applicable FDA and ICH requirements and alignment with corporate objectives.
• Guide regulatory submissions including INDs, NDAs, and sNDAs.
• Lead and manage interactions with regulatory agencies.
• Assess regulatory risk and provide strategic guidance to influence portfolio decisions.
• Partner cross-functionally to support patient-focused development goals.

Qualifications & Skills

• Strong expertise in regulatory strategy, planning, and lifecycle compliance.
• Proven ability to lead regulatory submissions and agency engagement.
• Advanced risk assessment and decision-influencing skills.
• Excellent cross-functional collaboration and communication.
• Deep understanding of FDA/ICH expectations for innovative therapies.