Regulatory Site Officer at Sanofi Aventis US LLC

Pocono Township, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Jun, 26

Salary

130000.0

Posted On

08 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Change Control Assessments, CMC Dossier Preparation, Variation Authoring, Regulatory File Maintenance, Regulatory Impact Analysis, Compliance Assurance, Audit Assistance, Communication Skills, Analytical Thinking, Project Management, Attention To Detail, GxP Regulation, Health Authority Interaction

Industry

Pharmaceutical Manufacturing

Description

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 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. 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: $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. Additional benefits information can be found through the LINK. Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

Responsibilities

The Regulatory Site Officer supports regulatory compliance for marketed products by managing compliant and timely regulatory activities at the Swiftwater site, including change control assessments and updating CMC files. This role involves authoring variations, CTD sections, and registration renewals in compliance with regulations and company processes.