Sanofi Ridgefield , NJ 07657
The Regulatory Compliance Specialist will provide both Chemistry Manufacturing and Controls (CMC) support and Quality support at the Sanofi Ridgefield site.
The Regulatory Compliance Specialist performs the role of a regulatory site officer within the quality organization. Routine regulatory activities include change assessment, dossier development for post-marketing changes, ensuring product and site renewals are completed on time, responding to health authority questions, and maintaining dossier compliance.
Depending on site needs, the Regulatory Compliance Specialist may also be assigned additional quality responsibilities.
CMC Documentation Management
Writes/Prepares/Manages CMC regulatory dossiers and GMP documents for submission
Coordinates and reviews CMC writing performed by subject matter experts
Optimizes the content of dossiers to facilitate the management of future changes
Prepares responses to Health Authority questions by working with site experts
Support marketing authorizations worldwide (territory extensions, renewals, site registrations, technical transfers) by preparing the CMC and GMP documentation
Ensures regulatory compliance required dates are met (responses to health authority questions, product renewals, global site registration renewals)
Performs periodic reviews to ensure the CMC dossier is in line with site manufacturing and control procedures
Assesses change controls to determine regulatory filing category for US and EU markets and manages change control activities with regulatory impact
Communicates details of change to Global Regulatory Affairs in order to determine appropriate filing categories in global markets
Provides regulatory expertise to site projects
Reviews/approves site documentation (specifications, batch records, SOPs, technical reports, deviations) to ensure site documentation is in line with the CMC dossier
Compiles regulatory updates and presents at management review meetings and annual product review meetings
Contributes to site inspections and audits
Communicates regulatory intelligence (guidance documents, regulations, directives) related directly to site products and operations
Support pharmacopoeia activities creation of new monographs, ensuring site compliance for changes to compendia
Bachelor's degree in science or engineering or similar experience is required with at least 4 years of CMC regulatory experience with NDA filings
Experience writing regulatory filings for parenteral products
Solid experience and understanding of health authorities' expectations for dossier content
Strong understanding of requirements for global regulatory filings (US, EU, JP, and international)
Strong project management/facilitator skills to oversee dossier development and review meetings and responses to health authority questions
Excellent organizational and project management skills
Strong communication (written and verbal) skills
Consistently demonstrate initiative and attention to detail
Strong collaboration skills
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.
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.
Sanofi, Empowering Life
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