Global Regulatory Lead - Immunology & Drug Development

Merck; Topeka (KS); Remote; USD 191,000 - 300,000; Full time

Benefits offered by this job

Annual bonus

Long‑term incentive

Comprehensive benefits

Job summary

Merck is seeking a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison to lead worldwide regulatory strategies for immunology programs.

The role requires strategic thinking, independent program management, and interaction with major health authorities to optimize labeling and accelerate approvals. You will manage global regulatory activities from development to lifecycle management, mentoring teams and coordinating regulatory submissions across multiple markets.

Qualifications

• Minimum 10 years of drug development experience with regulatory focus (BS/MS)
• 7+ years regulatory experience with MD/PhD/PharmD pathways
• Experience with global regulatory authorities (FDA, EMA) and cross‑functional teams

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and speed approvals.
• Acts as global regulatory lead and single point of contact for development programs.
• Leads regulatory meetings with health authorities (FDA/EMA) and cross‑functional teams.
• Oversees preparation and submission of regulatory documents and dossiers.
• Mentors global regulatory team and coordinates cross‑functional support.

Skills

Global Regulatory

Drug Development

Regulatory Submissions

Regulatory Strategy

Regulatory Communications

Labeling

Leadership

Education

BS/MS in related field

MD/PhD/PharmD preferred

Job description

Merck is seeking a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison to lead worldwide regulatory strategies for immunology programs.

The role requires strategic thinking, independent program management, and interaction with major health authorities to optimize labeling and accelerate approvals. You will manage global regulatory activities from development to lifecycle management, mentoring teams and coordinating regulatory submissions across multiple markets.