Remote Global Regulatory Lead - Immunology

HireLifeScience; Boston (MA); On-site; USD 191,000 - 300,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ, USA seeks a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison to develop worldwide regulatory strategies in General Medicine with a focus on Immunology.

The role leads global regulatory teams, interfaces with health authorities (FDA/EMA), coordinates filings (IND/CTAs) and drives labeling optimization and speed to approval across markets.

Qualifications

• Experience designing and implementing global regulatory strategies.
• Proven track record with major Health Authorities (FDA/EMA).
• Strong strategic thinking and leadership in cross-functional teams.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and approvals.
• Interacts with FDA/EMA and leads regulatory meetings and filings.
• Leads cross-functional teams to support development programs and marketed products.
• Coordinates IND/CTAs and regulatory documentation for global studies.
• In charge of regulatory due diligence for licensing reviews.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Regulatory Submissions

Strategic Leadership

Regulatory Strategy Development

Regulatory Communications

Regulatory Documents

Regulatory Strategies

Product Registrations

Regulatory Affairs Management

Education

B.S./M.S. with 10+ years of drug development experience

M.D./PharmD/Ph.D. with 7+ years in regulatory

Job description

Merck & Co., Inc. in Rahway, NJ, USA seeks a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison to develop worldwide regulatory strategies in General Medicine with a focus on Immunology.

The role leads global regulatory teams, interfaces with health authorities (FDA/EMA), coordinates filings (IND/CTAs) and drives labeling optimization and speed to approval across markets.