Remote Global Regulatory Lead, Immunology

MSD; United States; Remote; USD 191,000 - 300,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Retirement benefits (401(k))

Paid holidays and vacation

Sick days and compassionate leave

Job summary

MSD is seeking a Senior Director, Regulatory Affairs Liaison to lead worldwide regulatory strategies for General Medicine with emphasis on immunology. The role acts as the global point of contact for regulatory strategy and submission across multiple programs, including biologics and small molecules.

You will independently manage complex programs, interact with global authorities, and direct cross-functional teams to optimize labeling and speed time to approval.

Qualifications

• BS/MS with majority regulatory drug development experience.
• MD/PhD/PharmD with at least 7 years in drug development and 5 years in regulatory roles.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and accelerate approvals.
• Leads interactions with major Health Authorities (FDA, EMA) and global agencies.
• Serves as global regulatory lead to Product Development Teams across the lifecycle.
• Provides leadership to the Global Regulatory Team coordinating cross-functional support.
• Manages preparation, submission, and follow-up with regulatory agencies.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Documents

Regulatory Processes

Regulatory Strategies

Regulatory Strategy Development

Regulatory Submissions

Strategic Leadership

Education

Bachelor's or Master’s degree (B.S./M.S.) in a relevant field

M.D. or PhD/PharmD with regulatory experience

Job description

MSD is seeking a Senior Director, Regulatory Affairs Liaison to lead worldwide regulatory strategies for General Medicine with emphasis on immunology. The role acts as the global point of contact for regulatory strategy and submission across multiple programs, including biologics and small molecules.

You will independently manage complex programs, interact with global authorities, and direct cross-functional teams to optimize labeling and speed time to approval.