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 GRA
• Provide leadership, guidance, and coordination to project teams of GRA CMC professionals in delivering specific development and marketed product objectives
• Represent GRA CMC on GRAT (Global Regulatory Affairs Team)
• Assures effective involvement with change control systems
• Interpret global regulations & appropriately apply, implement, and communicate regulation, established or draft guidance's. Identify regulatory opportunity and risk.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 company
• Identify, communicate, and manage resolution to routine/complex regulatory CMC issues. Articulate the implication of issue to project team risk/benefit strategic component
• Assures that positive and collaborative relationships are developed with CMC teams to achieve the implementation of appropriate regulatory strategies
• Assures 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 necessary
• Assures 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 relationships
• Responsible 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 solutions
• Contributes 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 experience
• 4-6+ years CMC regulatory experience preferred
• Preparation & management of filings; ensuring thoroughness, accuracy, timeliness of CMC dossiers & responses
• Preparation of major filing; experience responding to Health Authority comments and issues related to submissions
• Manufacturing, QA/QC experience desirable

Soft skills:

• Experience working in a matrix environment and excellent people skills are required
• Previous experience working in a fast-paced environment on multiple product lines
• Strong organization skills
• Concise, informative and persuasive communication skills to impact project teams and HA interactions
• Potential to be able to mentor and train staff is desirable but not essential

Technical skills:

• Foundational understanding of Artificial Intelligence and impact on industry
• Strong background in drug development, manufacture, or testing
• Familiarity with combination products
• Proficient in MS Word, Excel, PowerPoint
• Demonstrated ability to work successfully on global project teams

Education:

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

Languages:

• Full proficiency in English

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