Regulatory Site Officer

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

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Job Title: Regulatory Site Officer

Location: Swiftwater, PA

About The Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The Regulatory Site Office, Vaccines will work closely with the Manufacturing and Supply teams and CMC colleagues on Vaccines based projects to achieve submissions and approvals in key markets and to maintain regulatory compliance for License registrations. The RSO management and position are based in Swiftwater, PA USA. This is a hybrid position.

About Sanof

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

Main Responsibilities

The RSO Within The Regulatory Site Office Supports Regulatory Compliance For Marketed Products By Means Of Compliant And Timely Handling Of Regulatory Activities At Swiftwater. The Incumbent Manages Change Control Assessments And Regulatory Activities Linked To Change Controls For The Site, Including The Update Of CMC Files. These Accountabilities Include

• Change Control Assessments
• PLC Management
• Authoring the variations, the CTD sections impacted by the changes, and the renewals of the site products registrations, in compliance with all applicable regulations and company processes
• Maintaining and updating regulatory files and databases
• Defining the potential regulatory impacts of changes made to the site products and services
• Ensuring compliance of the site products with all relevant product registrations, laws, regulations, standards, and guidelines in the markets where the site operates
• Assisting in internal and external audits, including regulatory inspections

About You

Basic Qualifications

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

Other Qualifications

• Experience with regulatory preparation of CMC dossier
• Well-developed communication skills, both verbal and written
• In-depth understanding of regulatory requirements and guidelines relevant to the pharmaceutical industry
• Ability to analyze complex regulatory documents and data to ensure compliance and identify potential issues
• Demonstrates initiative, analytical thinking and works independently
• Proficiency in managing multiple regulatory projects simultaneously, ensuring timely submissions and compliance
• High level of accuracy and attention to detail in preparing and reviewing regulatory documents and reports
• Experience working with a Health Authority is helpful but not essential

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Aff…

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.