Regulatory Site Officer

Sanofi; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

High-quality healthcare

Parental leave (gender-neutral)

Wellbeing programs

Job summary

Sanofi seeks a Regulatory Site Officer in Swiftwater, PA, a hybrid role to ensure regulatory compliance for vaccines at the site. You will manage change controls, update CMC files, and oversee registrations across markets.

You will collaborate with Manufacturing, Supply and CMC teams to maintain regulatory filings, support audits, and ensure timely submissions and ongoing compliance for site products.

Qualifications

• Bachelor's Degree in a relevant field.
• 3+ years' experience in regulatory affairs, change control or technical writing.
• OR 10 years in GxP regulated fields.
• Strong written and verbal communication skills.
• Ability to analyze complex regulatory documents for compliance.

Responsibilities

• Change Control Assessments and regulatory activities for the site.
• PLC Management and authoring variations and CTD sections.
• Renewals of site product registrations in compliance with regulations.
• Maintain and update regulatory files and databases.
• Define regulatory impacts of changes to products/services.
• Assist in internal and external audits and regulatory inspections.

Skills

Regulatory Affairs

Change Control

Technical Writing

GxP Knowledge

Education

Bachelor's Degree

Job description

**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** We’re an R&D-driven, AI-powered biopharma company committed to improving people’s 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 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#LI-Onsite#Vhd# Pursue *progress*, discover *extraordinary*Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here*US and Puerto Rico Residents Only*Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.*North America Applicants Only*The salary range for this position is:$90,000.00 - $130,000.00 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.