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Sanofi Group Change Control Assessment & Coordination (CCAC) Manager - Vaccine in Swiftwater, Pennsylvania

The Change Control Assessment & Coordination (CCAC) Manager has the responsibility of one or several Transversal Activities. 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 Industrial Affairs and Regulatory Affairs. The CCAC member also ensures optimal processes and related procedures. As per the assignment, this position acts/behaves as a support in the Reg CMC Conformance group as well as other functions of IA, 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 Assessment : As per the assignment the CCAC member and as part of the global team, coordinates the activity related to change control including:

o 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

o Entry of those Regulatory assessments into the Regulatory databases

o Communication of key country assessments to Quality Operations to facilitate IA action planning and appropriate blocking of batches pending regulatory approvals.

o At time of assessment of Annual Report level changes, completes the Annual report forms (US) or tabular listing (CA) and, coordinate submission

o Ensures maintenance of CCR tracking and information in the team SharePoint

Organizational Reporting and Communication: CCAC member is responsible for reporting on progress and specific issues pertaining to CMC responsibilities and ensures appropriate communication.

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:

o 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 the organization and to relevant functional areas and impacted project team(s) regarding communications/feedback from regulatory authority

o Sets up the necessary meetings with regulatory authorities/third parties and coordinates the preparation of the pre-reads and the presentations, in connection with the other functions of Regulatory Affairs.

Health Authority (HA) Inspection Preparation/Support and Other RA Process Development Support : The CCAC member may:

o Participate and provide support in inspection preparation and inspections, as requested.

o 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:

o Providing information from regulatory requirements documents and other appropriate guidance documents.

o Providing training and education/guidance on regulatory policies, procedures and other regulatory documents in collaboration with other RA functions.

Personal Development : Responsible for staying up-to-date on regulatory guidance's and technical/scientific developments. Assesses impact on areas of product responsibilities and comments on draft regulations as appropriate and may assess future areas for influencing the regulatory environment. The CCAC member may participate in management of RA staff, including development, coaching, and performance appraisal of staff, as appropriate

Knowledge and Skills:

Demonstrated critical thinking and leadership skills with an understanding of:

  • Process validation

  • Test methodology

  • Sterility Assurance

  • Stability Monitoring

  • Regulations and Guidelines from various countries which govern changes to marketed products.

  • Technical and regulatory requirements related to CTD

  • Familiarity with ICH guidelines, and Pharmacopoeias

  • Knowledge in electronic documents management systems, databases and MA dossiers.

  • Good level of expertise in planning methods and tools.

  • Ability to coordinate, organize and plan in an efficient and effective manner.

  • Ability to deal with conflicting priorities in constantly changing environment.

  • Negotiation and communication skills with internal and external stakeholders.

  • Ability to work in multidisciplinary and multicultural environment.

Experience:

  • At least 2-3 years in Regulatory Affairs or Quality Assurance with Change Control experience preferred.

  • Experience in dossier submissions to Health Authorities.

  • Experience in project and dossier planning.

  • Experience with international regulations and submissions would be beneficial.

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health.This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

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.

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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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