Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail. 

This job offer is accessible to all, regardless of gender. 

Job title: GRA CMC lead Vaccine

About the job

The Chemistry, Manufacturing and Controls (CMC) regulatory team is accountable for the global regulatory strategy for development and marketed products within GRA. The team responsibilities include but are not limited to: global regulatory CMC strategies, submission dossiers and approvals, direct contact/liaison with FDA/EMA for new and marketed chemical entities. The team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Industrial Affairs, Regulatory Health Authorities, and others. The team demonstrates behaviors that live and promote the Sanofi Play to Win behaviors and GRA Values/Principles/Competencies.

Main responsibilities:

 

Develop global regulatory CMC strategies and risk assessments for development projects and/or marketed products (new or marketed chemical entities, biological entities, and/or vaccine products) in collaboration with other parts of GRAProvide leadership, guidance, and coordination to project teams of GRA CMC professionals in delivering specific development and marketed product objectivesRepresent GRA CMC on GRAT (Global Regulatory Affairs Team)Assures effective involvement with change control systemsInterpret global regulations & appropriately apply, implement, and communicate regulation, established or draft guidance's. Identify regulatory opportunity and risk. Anticipate and communicate possible regulatory paradigm shifts that impact the companyIdentify, communicate, and manage resolution to routine/complex regulatory CMC issues. Articulate the implication of issue to project team risk/benefit strategic componentAssures that positive and collaborative relationships are developed with CMC teams to achieve the implementation of appropriate regulatory strategiesAssures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified and communicated as necessaryAssures that appropriate contacts with Health Authorities , in collaboration with Country Regulatory Groups, are initiated and addressed in an effective and timely manner, whilst developing positive and favorable relationshipsResponsible for direct contact/liaison with US FDA and EMA. Supports strategic negotiations with worldwide Regulatory Health Authorities so that appropriate and pragmatic positions are negotiated with the highest Probability of Success (POS)Manages or directly contributes to the CMC writing, preparation, review and approval of regulatory CMC dossiers for submission in collaboration with R&D Functions, Manufacturing & Supply Functions and GRA Regulatory Operations. Assures that submission dossiers meet appropriate quality standards; strategies and mitigated risks are developed and communicated, and deadlines are achieved. Assures that technical and regulatory CMC issues are appropriately resolved with optimal solutionsContributes knowledge and expertise on GRA Regulatory Science and Policy activities, as well as other related internal or external policy initiatives, in order to assure that appropriate Sanofi visibility and input is recognized. Monitors the review of local and international Health Authority regulations and guidelines, contributes to the commenting process and/or develops position papers. Assures that current Health Authority thinking and trends (paradigm shifts) are understood and broadly communicated As applicable, support the regulatory inspection process for development projects and marketed products

 

About you

 

Experience:

4-8+ years pharmaceutical or related experience4-6+ years CMC regulatory experience preferredPreparation & management of filings; ensuring thoroughness, accuracy, timeliness of CMC dossiers & responsesPreparation of major filing; experience responding to Health Authority comments and issues related to submissionsManufacturing, QA/QC experience desirable

Soft skills:

Experience working in a matrix environment and excellent people skills are requiredPrevious experience working in a fast-paced environment on multiple product linesStrong organization skillsConcise, informative and persuasive communication skills to impact project teams and HA interactionsPotential to be able to mentor and train staff is desirable but not essential

Technical skills:

Foundational understanding of Artificial Intelligence and impact on industryStrong background in drug development, manufacture, or testingFamiliarity with combination productsProficient in MS Word, Excel, PowerPointDemonstrated ability to work successfully on global project teams

Education:

B.A./B.S. degree in a scientific disciplineAdvanced degree (Masters, PhD) in a science or health field is desirable

Languages:

Full proficiency in English

Pursue Progress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
 

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

#LI-FRA

#LI-Hybrid

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!