The Regulatory CMC Manager / Product Focal Point (PFP) has the responsibility of one or several products/valences in the Reg CMC Vaccines group.
The CMC Manager / PFP develops the product(s) CMC submission strategy and is responsible for managing all the regulatory CMC aspects throughout the life cycle of the product(s) he/she has in charge from development (where necessary) through post licensure.
The CMC Manager / PFP represents RA with R&D or IA project teams when product or valence-related regulatory CMC expertise is required.
A CMC Manager / PFP can also be mandated to lead a transverse regulatory project (such as coordination of a variation impacting several products) or one submission in a given country.
The CMC Manager / PFP can be mandated by the manager to organize and lead contacts with regulatory agencies or third parties regarding CMC submissions and/or activities.
The CMC Manager / PFP may also represent RA for inspection readiness activities and/or in physical / virtual inspections taking place with Health Authorities and/or governing bodies.
Regulatory Strategy: As per the assignment the CMC Manager / PFP, develops the regulatory CMC strategy for the project(s)/product(s) assigned. This involves:
Compiling all the relevant information necessary to support the best regulatory CMC strategy for registration of a new vaccine or a license update in all concerned countries.
Developing and maintaining the Regulatory CMC Strategy Document (GCRSD) when applicable and keeping the document updated throughout the life of the project/product. Ensuring the coordination with the different areas concerned : Clinical Development, Product Development, Marketing and CMC related functions.
Contributing to the Global Regulatory Product Strategy (GRPS) as requested via the GRT and/or GRTL
Participating and performing change control assessment (CCRs) (for major markets) of any necessary changes proposed by IA and preparing the RSID and implementation plan with a global view for the impacted product(s).
Regulatory Submissions: Responsible for Modules 2 and 3 of the CTD for applicable marketing applications, related amendments or variations and all routine license maintenance activities, as well as providing support for all applicable products in all phases of development. For new marketing applications, the CMC Manager / PFP coordinates the creation of the module 2.3 and module 3 Common Technical Documents (CTD) for Licence Applications wherever filing is approved via the RAP, Global Project Team or otherwise.
As per the assignment, the CMC Manager / PFP:
Executes and implements the defined regulatory strategy and/or GCRSD via relevant CMC submissions.
Prepares and coordinates the creation of the CMC documents in support of complete license applications (CTD, IND, BLA, etc.) and other regulatory submissions for regulatory authorities and/or third parties.
Authors CMC related documents/summaries, coordinates reviews and approvals, and provides editorial review for all CMC components of regulatory applications and submissions.
Ensures preparation of the CMC components of the submission within pre-defined schedules in accordance with relevant RA procedures, tools, and templates, and coordinates the final submissions.
Anticipates any delays in pre-defined submissions, finds the root cause, sets-up corrective action plan and/or proposes alternate solutions.
Organizational Reporting and Communication:
As per the assignment, the Regulatory CMC Manager / PFP will work jointly with GBU / Global Regulatory Team Leads (GRTLs) / Subject Matter Experts / etc. for the planning and coordination of regulatory CMC activities relating to projects/products from initiation to approval, which include:
Detailed plan prioritization and coordination of activities
Developing CMC related regulatory objectives and target dates.
Providing timelines for critical CMC regulatory activities to be incorporated into the project plan.
Appropriate documentation / follow-up in Veeva RT (RA document manage system).
Health Authority (HA) Contacts and Communications:
As per the assignment, the Regulatory CMC Manager / PFP manages contacts with regulatory agencies or third parties related to CMC issues.
Responsible for the notification / communication to the most appropriate individuals within the company based upon the topic criticality of the issues to be addressed.
Discusses and negotiates issues with regulatory authorities/third parties; and communicates, documents and archives information for the organization.
Responsible for notification 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, in connection with the GRT.
Health Authority (HA) Commitments & Documents:
Health Authority (HA) Inspection Preparation/Support and Other RA Process Development Support: The Regulatory CMC Manager / PFP might:
Participate and provide support in all applicable inspection preparation activities and inspections, as requested.
Provides project/product-related input and resources towards the development and implementation of new RA systems, procedures, and/or tools.
Responsible for providing regulatory CMC advice and guidance to Project/Product Team members and other functional areas on regulatory matters. This could 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 Regulatory Operations.
Personal Development / Training:
Responsible for staying up-to-date on regulatory guidances and technical/scientific developments. Assesses impact on areas of product responsibilities, communicates to organization and, in collaboration with internal / company comments on draft regulations and assesses future areas for influencing the regulatory environment. The Regulatory CMC Manager / PFP may participate in management of RA staff, including development, coaching, and performance appraisal of staff, as appropriate.
Maintaining 100% compliance on all assigned and applicable training on a regular basis.
Main focus/challenge will be on the development and execution regulatory CMC strategy for the assigned components of regulatory applications and submissions and for the management and coordination of various regulatory activities throughout the life of the project/product.
Additional focus/challenge will be on the appropriate planning for prioritization and coordination of activities among functional areas and within Regulatory Affairs, and for timely identification and communication of project/product related concerns to the upper management such that they can be addressed/resolved in a timely manner.
Bachelor’s degree with 5+ years Regulatory Affairs experience OR Master’s degree in Regulatory Affairs with 2 year of Regulatory Affairs / Industry Experience.
Requires in depth knowledge and understanding of CMC topics, as well as North American, European and International regulations/guidelines.
Ability to manage multiple priorities efficiently.
Experience working on effective and cross-functional project teams.
Demonstrated knowledge of microbiology, immunology, virology or bacteriology.
Demonstrated skills in communication, writing and teamwork
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.
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.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
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.