R2814855 Regulatory Site Office Manager
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 Manager, Vaccines will work closely with the Manufacturing and Supply teams, and CMC colleagues on the regulatory assessment of Vaccines site-based projects to achieve submissions and approvals in key markets and to maintain regulatory compliance for License registrations in existing markets.
The RSO management and position are based in Swiftwater, PA USA. This is a hybrid position.
The RSO Manager 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. The incumbent is accountable for product license maintenance and site registrations. The incumbent also ensures the role of regulatory expert for regulatory topics and projects at Swiftwater.
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
Main Responsibilities:
Lead regulatory compliance for assigned vaccine products at Swiftwater site, including change control assessments and supplier change notifications.
Author and manage CMC regulatory documentation for global marketing authorizations, site registrations, and annual reports.
Ensure regulatory compliance for batch release processes and maintain product license requirements across multiple markets.
Prepare and coordinate responses to Health Authority questions, working with site experts and regulatory affiliates.
Serve as regulatory expert on Manufacturing & Supply project teams, providing strategic guidance on regulatory requirements and impact assessments.
Support site inspection readiness and participate in Health Authority audits/inspections.
Review and approve critical site documentation including SOPs, technical reports, and Site Master File updates.
Coordinate with global Regulatory Affairs teams to ensure alignment of CMC strategies and timely completion of regulatory submissions.
Drive continuous improvement in regulatory processes through participation in system/tool development and regulatory intelligence activities.
Manage multiple regulatory projects while ensuring effective communication with stakeholders and timely delivery of objectives
About You
Bachelor's degree in science with 2 years of Regulatory Affairs experience OR master's degree in science with 1 year of experience.
Demonstrated knowledge of CMC documentation and regulatory requirements
Understanding of North American, European, and international pharmaceutical/vaccines regulations/guidelines
Background knowledge in microbiology, immunology, virology, or bacteriology is preferred.
Proven ability to manage multiple priorities efficiently
Experience working in cross-functional project teams
Strong written and verbal communication skills
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.
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.
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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.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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:
$84,750.00 - $122,416.66All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.