Vaccines Regulatory Site Lead

Sanofi; Pocono Township (PA); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Sanofi is seeking a Regulatory Site Officer in Swiftwater, PA, to ensure regulatory compliance for vaccines and manage changes across CMC and site registrations. The role partners with Manufacturing & Supply and CMC teams.

The incumbent will handle CTD changes, prepare regulatory documents, and support audits as part of a hybrid work arrangement in the US. A bachelor's degree and GxP experience are required.

Qualifications

• Bachelor’s degree required.
• 3+ years’ experience in regulatory affairs, change control or technical writing.
• Alternatively 10 years in GxP regulated fields.

Responsibilities

• Manage change control assessments and regulatory activities linked to site change controls.
• Author CTD sections impacted by changes and renewals of site product registrations.
• Maintain and update regulatory files and databases.
• Define potential regulatory impacts of changes to site products and services.
• Assist in internal and external audits, including regulatory inspections.

Skills

Communication skills

Regulatory affairs

GxP knowledge

Education

Bachelor's Degree

Job description

Sanofi is seeking a Regulatory Site Officer in Swiftwater, PA, to ensure regulatory compliance for vaccines and manage changes across CMC and site registrations. The role partners with Manufacturing & Supply and CMC teams.

The incumbent will handle CTD changes, prepare regulatory documents, and support audits as part of a hybrid work arrangement in the US. A bachelor's degree and GxP experience are required.