Manufacturing and Supply
Where the
miracles of
science are made
a reality for patients

Job Title: Regulatory Site Officer

• Location: Swiftwater, PA

About the Job

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 Sanofi:

 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.

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/ILVF 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 within the pharmaceutical industry, 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 it’s 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 Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SP

#LI-SP

#vhd

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.

Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com