Sanofi Group Change Control Assessment & Coordination (CCAC) Manager in Swiftwater, Pennsylvania
Change Control Assessment & Coordination (CCAC) Manager
Reference #: R2503272
Department: Regulatory Affairs
Location: Toronto, Ontario
About Sanofi Pasteur
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.
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.
The Change Control Assessment & Coordination (CCAC) Manager has the responsibility of one or several Transversal Activities in the International CMC Strategy and Assessment (ISCA) group. For these activities, the CCAC member acts as a single point of contact for the coordination of related requests emanating from both local and global Vaccine Industrial Affairs (VIA) and Regulatory Affairs. As per the assignment, this position acts/behaves as a support in the Reg CMC Conformance group as well as other functions of VIA, Research and Development and Regulatory Affairs.
The CCAC member could be mandated by the manager to organize and lead contacts with regulatory agencies or third parties regarding regulatory impact of Industrial changes and is responsible for the following:
Change Control: As per the assignment the CCAC member and as part of the global team, coordinates the activity related to change control including:
Timely screening and assessment of appropriate and consistent regulatory reporting and associated strategies to worldwide Health
Authorities for industrial and quality changes coordinated at all manufacturing sites in scope.
Entry of those Regulatory assessments into the Regulatory databases.
Communication of key country assessments to Quality Operations to facilitate IA action planning and appropriate blocking of batches pending regulatory approvals.
Ensures maintenance of CCR tracking and information in the ICSA team SharePoint.
Organizational Reporting and Communication: CCAC member is responsible for reporting on progress and specific issues pertaining to CMC responsibilities and ensures appropriate
Health Authority (HA) Contacts and Communications: The CCAC member might manage contacts with regulatory agencies or third parties related to CC issues and if so is responsible to:
Notify and recommend the inclusion of the most appropriate individuals within the company based upon the criticality of the issues to be addressed.
Discuss and negotiate issues with regulatory authorities/third parties; and communicates, documents and archives information for organization and to relevant functional areas and impacted project team(s) regarding communications/feedback from regulatory authority.
Sets up the necessary meetings with regulatory authorities/third parties and co-ordinates the preparation of the pre-reads and the presentations, connection with the other functions of Regulatory Affairs.
Author, review, approve and/or contribute to submission documents (Annual Reports) for regulatory files (BLAs and CTDs, etc.) for US and Canada.
Health Authority (HA) Inspection Preparation/Support and Other RA Process Development Support. The CCAC member may:
Participate and provide support in inspection preparation and inspections, as requested.
Provides project/product-related input and resources towards the development and implementation of new RA systems, procedures, and/or tools.
Regulatory Guidance: Responsible for providing regulatory CMC advice and guidance to Project/Product Team members and other functional areas on regulatory matters. This may include:
Providing information from regulatory requirements documents and other appropriate guidance documents.
Providing training and education/guidance on regulatory policies, procedures and other regulatory documents in collaboration with other RA functions.
Education and Experience
University degree in scientific discipline with 3-5 years regulatory experience.
Knowledge of Health Authority guidances/regulations is essential.
Experience with biological product manufacturing.
Proficient in MS Word, Excel, PowerPoint, MS Project, and Trackwise..
Excellent organizational and communication (written and verbal) skills.
Demonstrated ability to work successfully on project teams.
RAC certification preferred.
Previous experience working in a fast paced environment on multiple product lines.
Manufacturing, Facility or QA/QC experience.
Fluency in French a preferred asset.
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to a ttract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
Sanofi, Empowering Life
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.
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