Global Regulatory Lead — Immunology, Remote

Merck; Lincoln (NE); Remote; USD 190,000 - 300,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentives

Comprehensive benefits

Job summary

Merck is seeking a Senior Director (Sr. Principal Scientist) in Regulatory Affairs to lead worldwide regulatory strategies for General Medicine Immunology programs. You will act as the global single point of contact, interacting with worldwide regulatory agencies and subsidiaries to optimize labeling and shorten time to approval.

You will independently manage complex programs across indications and formulations, with strong emphasis on Immunology experience and strategic leadership.

Qualifications

• Minimum 10 years in drug development with majority in regulatory.
• MD/PhD/PharmD candidates must have at least 7 years in regulatory.
• Experience interacting with major Health Authorities (FDA/EMA) is required.

Responsibilities

• Lead global regulatory strategy to optimize labeling and approval timelines.
• Serve as single global regulatory contact for development programs.
• Direct regulatory submissions and communications with agencies.
• Coordinate cross-functional teams and regulatory support for products.
• Prepare for FDA advisory committee activities where applicable.
• Review and approve global study protocols for marketing authorization.

Education

Bachelor's or Master's in science

MD/PhD/PharmD

Tools

FDA/EMA interactions

Regulatory strategy

Regulatory submissions

Global regulatory

Strategic leadership

Cross-functional collaboration

Job description

Merck is seeking a Senior Director (Sr. Principal Scientist) in Regulatory Affairs to lead worldwide regulatory strategies for General Medicine Immunology programs. You will act as the global single point of contact, interacting with worldwide regulatory agencies and subsidiaries to optimize labeling and shorten time to approval.

You will independently manage complex programs across indications and formulations, with strong emphasis on Immunology experience and strategic leadership.