Regulatory Compliance Specialist
Ridgefield, New Jersey
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our manufacturing and production facilities are seeking a successful candidate to help ensure production units are running smoothly, required materials are available in a timely manner, and procedures are in line with regulations. The candidate should also have a familiarity with reading/writing SOP's with and batch records and coordinating activities with related groups(Quality, Validation, Metrology, and Facilities). The candidate will participate in clinical manufacturing under cGMP regulations which include; sampling, analyzing, documenting, witnessing production events, and equipment reprocessing. The successful candidate should have the ability to operate complex systems and equipment using batch records and SOPs in accordance with current GMPs and safety guidelines under limited supervision. Weekend work may be required for some on a rotating basis.
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HEALTH AND WELLNESS PROGRAMS
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Employer matching because Sanofi invests in their employees!
Sanofi is eager to further your development and expertise in an ever challenging environment.
Sanofi understands the importance of family. We offer a variety of support including maternity/paternity leave.
PAID TIME OFF
Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!
Importance of life outside of the office is valued at Sanofi.
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
- Regulatory Compliance
- 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
- Change Control
- 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
- RAPS certificate
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 diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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