Senior Regulatory Strategist Immunology (Remote)

Merck; North Wales (Montgomery County); Remote; USD 191,000 - 300,000; Full time

Job summary

Merck seeks a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison, to lead worldwide regulatory strategies in General Medicine with a focus on Immunology. You will partner with product teams and regulators to accelerate labeling and approvals across global markets.

You will interact with FDA/EMA, oversee submissions, and guide the regulatory roadmap from development through lifecycle, while managing a high-performing team. Remote work and ~10% travel are offered.

Qualifications

• B.S. or M.S with a minimum of 10 years of drug development experience, majority in regulatory.
• M.D. or PhD/PharmD with a minimum of 7 years relevant drug development experience, with five years in regulatory.

Responsibilities

• Develop worldwide regulatory strategies to optimize labeling and shorten time to approval.
• Lead regulatory interactions with major Health Authorities (FDA, EMA).
• Provide Global Regulatory Lead guidance to Product Development Teams.
• Coordinate preparation, submission and follow-up communications with regulatory agencies.
• Lead cross-functional regulatory teams and support lifecycle activities.
• Prepare IND/CTAs for global studies.
• Participate in regulatory due diligence for licensing reviews.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Documents

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Education

B.S./M.S. in relevant field

M.D./PhD/PharmD with 5+ regulatory years

Job description

Merck seeks a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison, to lead worldwide regulatory strategies in General Medicine with a focus on Immunology. You will partner with product teams and regulators to accelerate labeling and approvals across global markets.

You will interact with FDA/EMA, oversee submissions, and guide the regulatory roadmap from development through lifecycle, while managing a high-performing team. Remote work and ~10% travel are offered.