Global Regulatory Scientist, Vaccine & Infectious Disease

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

Job summary

Merck & Co., Inc. in Rahway, NJ seeks an Associate Principal Scientist, Regulatory Affairs to help develop and implement global regulatory strategies for the Vaccine and Infectious Disease (VID) portfolio.

You will support regulatory submissions and agency communications in collaboration with a global liaison and regulatory team. The role emphasizes conducting research on guidelines and competitive intelligence, coordinating with Regulatory Operations, Clinical Safety, Labeling, and CMC, and

Qualifications

• MD/PhD or related doctoral degree in biological science, chemistry or related discipline; other degrees acceptable with experience.
• Doctoral degree with 3+ years pharma experience or Bachelor's with 6+ years.
• Excellent communication skills.
• Strong organizational and multitasking abilities.
• Flexibility and adaptability.
• Strong scientific and analytical skills.

Responsibilities

• Assists in regulatory agency communications and submissions (INDs, marketing applications, pediatric plans, annual reports).
• Implements strategy to develop agency background packages for marketing applications.
• Communicates with agencies and attends agency meetings to aid the Global Liaison.
• Participates in the Global Regulatory Team and cross-functional meetings.
• Researches guidelines, regulatory precedents, and competitive intelligence to develop regulatory strategy.
• Collaborates with Regulatory Operations, Clinical Safety, Labeling, CMC, and other functions on regulatory matters.
• Supports maintenance and life cycle management of VID programs.
• Supports label development with Global Liaison.
• Participates in process improvement initiatives.
• Performs regulatory administrative activities.

Skills

MD/PhD or related doctoral degree

Excellent communication

Organization skills

Flexibility

Analytical skills

Regulatory experience

Bachelor's degree

Education

MD/PhD or related doctoral degree

Master's degree with relevant experience

Bachelor's degree with 6 years experience

Job description

Merck & Co., Inc. in Rahway, NJ seeks an Associate Principal Scientist, Regulatory Affairs to help develop and implement global regulatory strategies for the Vaccine and Infectious Disease (VID) portfolio.

You will support regulatory submissions and agency communications in collaboration with a global liaison and regulatory team. The role emphasizes conducting research on guidelines and competitive intelligence, coordinating with Regulatory Operations, Clinical Safety, Labeling, and CMC, and