Regulatory Site Officer

Summary

About The JobWe 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.Job TitleRegulatory Site OfficerLocationSwiftwater, PAAbout The JobWe 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 SanofWere an R&D-driven, AI-powered biopharma company committed to improving peoples 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 ResponsibilitiesThe 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 IncludeChange Control AssessmentsPLC ManagementAuthoring 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 processesMaintaining and updating regulatory files and databasesDefining the potential regulatory impacts of changes made to the site products and servicesEnsuring compliance of the site products with all relevant product registrations, laws, regulations, standards, and guidelines in the markets where the site operatesAssisting in internal and external audits, including regulatory inspectionsAbout YouBasic QualificationsBachelor's Degree3 + years' experience in regulatory affairs, change control or technical writingOR 10 years in GxP regulated fieldsOther QualificationsExperience with regulatory preparation of CMC dossierWell-developed communication skills, both verbal and writtenIn-depth understanding of regulatory requirements and guidelines relevant to the pharmaceutical industryAbility to analyze complex regulatory documents and data to ensure compliance and identify potential issuesDemonstrates initiative, analytical thinking and works independentlyProficiency in managing multiple regulatory projects simultaneously, ensuring timely submissions and complianceHigh level of accuracy and attention to detail in preparing and reviewing regulatory documents and reportsExperience working with a Health Authority is helpful but not essentialWhy 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 its 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 scaleTransform lives worldwide by delivering life-changing treatments anywhere, anytime.Sanofi Inc.Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affimative 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#VhdCompensation & BenefitsAll 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.#J-18808-Ljbffr

Job Description

About The JobWe 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.Job TitleRegulatory Site OfficerLocationSwiftwater, PAAbout The JobWe 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 SanofWere an R&D-driven, AI-powered biopharma company committed to improving peoples 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 ResponsibilitiesThe 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 IncludeChange Control AssessmentsPLC ManagementAuthoring 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 processesMaintaining and updating regulatory files and databasesDefining the potential regulatory impacts of changes made to the site products and servicesEnsuring compliance of the site products with all relevant product registrations, laws, regulations, standards, and guidelines in the markets where the site operatesAssisting in internal and external audits, including regulatory inspectionsAbout YouBasic QualificationsBachelor's Degree3 + years' experience in regulatory affairs, change control or technical writingOR 10 years in GxP regulated fieldsOther QualificationsExperience with regulatory preparation of CMC dossierWell-developed communication skills, both verbal and writtenIn-depth understanding of regulatory requirements and guidelines relevant to the pharmaceutical industryAbility to analyze complex regulatory documents and data to ensure compliance and identify potential issuesDemonstrates initiative, analytical thinking and works independentlyProficiency in managing multiple regulatory projects simultaneously, ensuring timely submissions and complianceHigh level of accuracy and attention to detail in preparing and reviewing regulatory documents and reportsExperience working with a Health Authority is helpful but not essentialWhy 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 its 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 scaleTransform lives worldwide by delivering life-changing treatments anywhere, anytime.Sanofi Inc.Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affimative 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#VhdCompensation & BenefitsAll 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.#J-18808-Ljbffr