Global Immunology Regulatory Lead — Remote

Merck; Hartford (CT); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Retirement

Paid Holidays

Vacation

Sick Leave

Job summary

Merck & Co., Inc. seeks a Director (Principal Scientist), Global Regulatory Liaison to develop and implement worldwide regulatory strategies for Immunology projects.

You will be the global point of contact for regulatory strategy and submissions, coordinating with agencies and cross-functional teams to optimize labeling and time to approval. The role requires strong leadership, proactive project management, and experience with major Health Authorities.

Qualifications

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

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and time to approval by agencies.
• Assesses regulatory/competitive landscape to establish global strategies for speed-to-market and labeling.
• Provides expert advice as Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products.
• Provides leadership to the Global Regulatory Team coordinating cross-functional regulatory support.
• Coordinates preparation, submission and follow-up with regulatory agencies and subsidiaries for all applications and submissions.
• Reviews local registration study protocols to obtain marketing authorization in secondary markets.
• Interacts with regulatory agencies (FDA, EMA) including meetings, teleconferences, and written communications.
• Coordinates regional regulatory strategy with Regulatory Affairs Europe and local affiliates.
• Reviews Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures.
• Prepares IND/CTAs for global studies related to investigational drugs/biologics.
• Participates in regulatory due diligence for licensing candidate reviews.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Education

B.S. or MS in related field

MD or PhD/PharmD with regulatory experience

Job description

Merck & Co., Inc. seeks a Director (Principal Scientist), Global Regulatory Liaison to develop and implement worldwide regulatory strategies for Immunology projects.

You will be the global point of contact for regulatory strategy and submissions, coordinating with agencies and cross-functional teams to optimize labeling and time to approval. The role requires strong leadership, proactive project management, and experience with major Health Authorities.