Senior Regulatory Scientist – Global Vaccine Liaison

MSD Malaysia; Northern (KY); Hybrid; USD 142,000 - 224,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ, and North Wales, PA, seeks an Associate Principal Scientist, Regulatory Liaison to help develop and implement global regulatory strategies for VID vaccines and infectious disease products.

The role involves coordinating with a global liaison, drafting submissions, and attending regulatory meetings to align with cross-functional teams. The candidate will support regulatory strategy, documentation, and lifecycle management, collaborating with Regulatory Operations,

Qualifications

• MD/PhD or related doctoral degree in biological sciences, chemistry or related field.
• Master’s degree with at least 3 years of relevant pharmaceutical industry experience or Bachelor’s with 6+ years of relevant experience.
• Excellent written and oral communication; strong organization and multitasking skills.

Responsibilities

• Assist regulatory submissions including INDs, marketing applications and periodic reports.
• Develop and implement global regulatory strategies for VID products.
• Coordinate with global liaison and cross-functional teams to prepare agency packages and responses.
• Conduct regulatory guideline research and competitive intelligence to inform strategy.
• Support regulatory operations, CMC, clinical safety, labeling and other functions as needed.

Skills

Adaptability

Cross-Functional Teamwork

Judgment

Life Cycle Planning

Meeting Facilitation

Pharmaceutical Industry

Pharmaceutical Research

Pharmaceutics

Process Improvements

Regulatory Affairs Management

Regulatory Communications

Regulatory Documents

Regulatory Experience

Regulatory Management

Regulatory Processes

Regulatory Reporting

Regulatory Strategies

Regulatory Strategy Development

Regulatory Submissions

Strategic Thinking

Strategy Development

Education

MD/PhD or related doctoral degree

Master’s degree with 3+ years pharma experience

Bachelor’s degree with 6+ years pharma experience

Job description

Merck & Co., Inc. in Rahway, NJ, and North Wales, PA, seeks an Associate Principal Scientist, Regulatory Liaison to help develop and implement global regulatory strategies for VID vaccines and infectious disease products.

The role involves coordinating with a global liaison, drafting submissions, and attending regulatory meetings to align with cross-functional teams. The candidate will support regulatory strategy, documentation, and lifecycle management, collaborating with Regulatory Operations,