Senior Scientist, Global Vaccines CMC & Regulatory Strategy

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

Benefits offered by this job

Benefits package

Job summary

HireLifeScience in the United States seeks a Regulatory Affairs professional to develop and implement regulatory strategies for pharma products, including CMC submissions and dossiers for commercialization.

You will lead global strategies, author and review submission components, coordinate with CROs/CMOs, and manage risk and timelines across product lifecycles while ensuring compliance with global guidelines.

Qualifications

• Bachelor's degree in science or related field; advanced degree preferred but not required.
• At least 5 years pharmaceutical regulatory experience, or up to 3 years in managing Regulatory submissions for small molecules/vaccines/biologics; experience with Veeva preferred.

Responsibilities

• Lead global regulatory strategies by identifying requirements and evaluating supporting documents for acceptability and risk.
• Develop, author and review CMC submission components and documentation for approvals, variations, and licenses.
• Coordinate with CMOs and external partners to ensure compliant change management and regulatory conformance.
• Assess regulatory risks and propose mitigation strategies to meet milestones across product lifecycles.

Skills

Adaptability

BLA

Cross-Cultural Awareness

Detail-Oriented

eCTD

Employee Training Programs

International Regulatory Compliance

Pharmaceutical Process Development

Regulatory Affairs Management

Regulatory Submissions

Regulatory Writing

Strategic Thinking

Technical Writing

Education

Bachelor's degree in science or related field

Tools

Veeva

Job description

HireLifeScience in the United States seeks a Regulatory Affairs professional to develop and implement regulatory strategies for pharma products, including CMC submissions and dossiers for commercialization.

You will lead global strategies, author and review submission components, coordinate with CROs/CMOs, and manage risk and timelines across product lifecycles while ensuring compliance with global guidelines.