Regulatory Site Officer, Vaccines — Hybrid

BioSpace; Swiftwater (Monroe County); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Hybrid work arrangement

14 weeks gender-neutral parental leave

High-quality healthcare benefits

Job summary

Sanofi in Swiftwater, PA, is seeking a Regulatory Site Officer to ensure regulatory compliance for vaccines, working closely with Manufacturing, Supply and CMC. The role is hybrid and based in Swiftwater; you will manage change controls, author variations and CTD sections, maintain regulatory files, and support audits.

Strong knowledge of GxP, regulatory submissions, and communication skills required; Bachelor's degree and 3+ years experience expected.

Qualifications

• Bachelor's degree required; 3+ years in regulatory affairs, change control or technical writing, or 10 years in GxP fields.
• Experience with regulatory preparation of CMC dossiers and CTD sections.
• Strong written and verbal communication skills; accuracy and attention to detail.

Responsibilities

• Support regulatory compliance for marketed products at Swiftwater; manage change controls.
• Lead change control assessments and PLC management.
• Author variations and CTD sections; renew site product registrations.
• Maintain and update regulatory files and databases.
• Assess regulatory impacts of changes; ensure product registrations meet regulations.
• Assist internal and external audits and regulatory inspections.

Skills

Regulatory affairs

Change control

Technical writing

GxP

Communication

Education

Bachelor's Degree

Job description

Sanofi in Swiftwater, PA, is seeking a Regulatory Site Officer to ensure regulatory compliance for vaccines, working closely with Manufacturing, Supply and CMC. The role is hybrid and based in Swiftwater; you will manage change controls, author variations and CTD sections, maintain regulatory files, and support audits.

Strong knowledge of GxP, regulatory submissions, and communication skills required; Bachelor's degree and 3+ years experience expected.