Hybrid Regulatory Site Lead, Vaccines

Sanofi; Pennsylvania; Hybrid; USD 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Parental leave

Health benefits

Wellbeing programs

Zusammenfassung

Sanofi is seeking a Regulatory Site Officer in Swiftwater, PA to oversee regulatory compliance for vaccines at the site. Hybrid work arrangement, coordinating with Manufacturing, Supply and CMC teams to ensure timely submissions and approvals, and to maintain registrations across markets.

The role requires a Bachelor's degree and 3+ years in regulatory affairs, with strong communication and analytical skills to manage complex regulatory documents and audits.

Qualifikationen

• Bachelor's Degree required.
• 3+ years in regulatory affairs, change control or technical writing, or 10 years in GxP fields.

Aufgaben

• Manage change control assessments and regulatory activities for Swiftwater site.
• Author variations and CTD sections; renew site product registrations.
• Maintain regulatory files and databases; assess regulatory impacts of changes.
• Assist in internal and external audits and regulatory inspections.

Kenntnisse

Communication

Regulatory requirements

Regulatory document analysis

Initiative & independence

Ausbildung

Bachelor's Degree

Jobbeschreibung

Sanofi is seeking a Regulatory Site Officer in Swiftwater, PA to oversee regulatory compliance for vaccines at the site. Hybrid work arrangement, coordinating with Manufacturing, Supply and CMC teams to ensure timely submissions and approvals, and to maintain registrations across markets.

The role requires a Bachelor's degree and 3+ years in regulatory affairs, with strong communication and analytical skills to manage complex regulatory documents and audits.