Senior Regulatory Scientist - Vaccine & Infectious Disease

MSD Malaysia; North Wales (Montgomery County); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck & Co., Inc. seeks a Regulatory Affairs Headquarters Associate Principal Scientist to drive global regulatory planning for VID products. You will work with a global liaison, preparing submissions, reviewing protocols, and researching regulatory guidance to shape strategy.

Collaboration across Regulatory Operations, Clinical Safety, Labeling, CMC and other functions is essential. The role emphasizes communication, project management, and life cycle planning with hybrid work arrangements and

Qualifications

• Requires MD/PhD or related doctoral degree in biological science, chemistry or related field.
• Excellent communication and organizational skills; ability to manage multiple projects.
• Preferred experience in regulatory affairs for vaccines or infectious diseases.

Responsibilities

• Assist in regulatory agency communications and submissions (INDs, marketing applications, pediatric plans).
• Lead or support responses to agency requests and develop regulatory strategy packages.
• Collaborate with Global Liaison and cross-functional teams to align regulatory plans.
• Research guidelines and competitive intelligence to inform strategy.
• Author regulatory strategy documents and contribute to life cycle management.

Skills

Regulatory strategy

Regulatory submissions

Regulatory communications

Cross-functional teamwork

Strategic thinking

Life cycle planning

Pharmaceutical industry

Regulatory documentation

Regulatory experience

Regulatory management

Regulatory processes

Regulatory reporting

Regulatory strategies

Regulatory strategy development

Regulatory submissions

Strategic thinking

Education

MD/PhD or related doctoral degree

Master’s degree (with pharma experience)

Bachelor’s degree (with pharma experience)

Job description

Merck & Co., Inc. seeks a Regulatory Affairs Headquarters Associate Principal Scientist to drive global regulatory planning for VID products. You will work with a global liaison, preparing submissions, reviewing protocols, and researching regulatory guidance to shape strategy.

Collaboration across Regulatory Operations, Clinical Safety, Labeling, CMC and other functions is essential. The role emphasizes communication, project management, and life cycle planning with hybrid work arrangements and