Regulatory Site Officer

Sanofi•Swiftwater, PA

22h•Hybrid

About The Position

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.

Requirements

Bachelor's Degree
3 + years experience in regulatory affairs within the pharmaceutical industry, or 10 years in GxP regulated fields
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

Nice To Haves

Experience working with a Health Authority is helpful but not essential

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.
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

Benefits

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.
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.
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.