Regulatory Site Officer

Sanofi • Pocono Township, PA

2d • 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level