Regulatory Site Officer

Sanofi; Pocono Township (PA); Hybride; USD 90 000 - 130 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Communication skills

Regulatory affairs

GxP knowledge

Formation

Bachelor's Degree

Description du poste

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 Aff1m.

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.

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.