Global Regulatory Strategy Lead, Vaccines/VID

MSD; Rahway (NJ); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) retirement benefits

Paid holidays and vacation

Hybrid work arrangement

Job summary

Merck & Co., Inc. Rahway, NJ: Regulatory Affairs Headquarters Associate Principal Scientist supports VID products with a global regulatory strategy and submissions. You will collaborate across functions and liaise with global teams to plan and implement regulatory activities and maintain lifecycle programs.

The role requires a PhD/MD or advanced degree with significant regulatory experience in pharma, strong communication, and the ability to manage multiple projects in a hybrid work setting.

Qualifications

• MD/PhD or related doctoral degree in biological science, chemistry or related field.
• Experience in regulatory submissions, strategy, and agency communications.
• Strong written and oral communication skills; detail-oriented.

Responsibilities

• Assist regulatory agency communications and submissions, including INDs and pediatric plans.
• Develop and implement global regulatory strategy for VID products.
• Collaborate with Global Liaison and cross-functional teams across functions (CMC, Clinical, Safety).
• Conduct regulatory research and prepare strategy documents; track agency requests.

Skills

Adaptability

Cross-Functional Teamwork

Life Cycle Planning

Meeting Facilitation

Regulatory Strategy Development

Regulatory Submissions

Strategic Thinking

Regulatory Communications

Regulatory Management

Regulatory Processes

Education

MD/PhD or related doctoral degree

Master’s degree with 3+ years regulatory experience

Bachelor’s degree with 6+ years pharmaceutical experience

Job description

Merck & Co., Inc. Rahway, NJ: Regulatory Affairs Headquarters Associate Principal Scientist supports VID products with a global regulatory strategy and submissions. You will collaborate across functions and liaise with global teams to plan and implement regulatory activities and maintain lifecycle programs.

The role requires a PhD/MD or advanced degree with significant regulatory experience in pharma, strong communication, and the ability to manage multiple projects in a hybrid work setting.