Senior Regulatory Scientist - Vaccine & Infectious Disease

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

Job summary

Merck & Co., Inc. in Rahway, NJ, USA seeks an experienced Regulatory Affairs Headquarters Associate Principal Scientist to help develop and implement global regulatory strategies for VID products, including submissions and agency communications.

You will collaborate with the Global Liaison and cross-functional teams (Clinical Safety, Labeling, CMC) to prepare background packages, review guidelines, and support lifecycle management.

Qualifications

• MD/PhD or related doctoral degree in biological science, chemistry or related discipline.
• Alternative: Master's or Bachelor's with equivalent experience.
• Excellent communication, organizational skills, flexibility and attention to detail.

Responsibilities

• Assist in regulatory agency communications and submissions including INDs, pediatric plans and annual reports.
• Implement strategy to develop background packages and documents for regulatory submissions.
• Communicate with agencies and attend agency meetings to assist the Global Liaison.
• Participate on the Global Regulatory Team and attend cross-functional meetings.
• Research guidelines and regulatory precedence to inform strategy; assist in drafting strategy documents.
• Collaborate with Regulatory Operations, Clinical Safety, Labeling, CMC and other functions to communicate regulatory strategy.
• Support maintenance of VID programs, label development and process improvements; perform regulatory administrative activities.

Skills

Excellent communication

Organizational skills

Flexibility

Analytical skills

Regulatory knowledge

Cross-functional teamwork

Education

MD/PhD or related doctoral degree

Master's degree with relevant experience

Bachelor's degree with 6+ years in pharma

Job description

Merck & Co., Inc. in Rahway, NJ, USA seeks an experienced Regulatory Affairs Headquarters Associate Principal Scientist to help develop and implement global regulatory strategies for VID products, including submissions and agency communications.

You will collaborate with the Global Liaison and cross-functional teams (Clinical Safety, Labeling, CMC) to prepare background packages, review guidelines, and support lifecycle management.