Manager, Global Regulatory Affairs CMC

Job title: Manager, Global Regulatory Affairs CMC

• Location: Bridgewater, NJ

About the job:

The Manager, Global Regulatory Affairs CMC is accountable for global strategic management of a portfolio of development projects and/or marketed products within GRA CMC & Devices Departments (Small Molecules Marketed, Small Molecules Development, Products, Biologics, and Vaccines). This individual is responsible for global regulatory CMC strategies, submission dossiers and approvals, including direct contact/liaison with FDA/EMA, for new or marketed chemical entities, biological entities, vaccines.

The incumbent creates collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Industrial Affairs, External Alliance Partners, Project Direction/Management (R&D Development, Pharma Operations teams), Human Resources, Legal, Finance, and Regulatory Health Authorities.

Main responsibilities:

• Develops global regulatory CMC strategies and risk assessments for development projects and/or marketed products (new or marketed chemical entities, biological entities, vaccines) in collaboration with other parts of GRA.Assures effective involvement with change control systems.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, communicated and mitigated 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 on specific CMC topics. 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, Industrial Affairs Functions and GRA Regulatory Operations. Ensures that submission dossiers meet appropriate quality standards; strategies and mitigated risks are developed and communicated, and deadlines are achieved.
• Ensures that technical and regulatory CMC issues are appropriately resolved with optimal solutions. As applicable, support the regulatory inspection process for development projects and marketed products.
• 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. 
• Engages with internal and external Regulatory Policy Organizations/Programs in order to develop and maintain appropriate Sanofi representation in these activities. 

About you:

• Minimum of a Bachelor’s Degree; advanced degree (Masters, PhD) in a science/health field (Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalentis preferred.
• 1-5 years of direct Regulatory CMC experience is preferred, however more than 5 years may be applicable for certain associates within an individual contributorcareer path.
• Global operational experience with a mid/large-size Regulatory CMC and Devices Organization.
• Must have some knowledge of global regulations/guidelines,key Health Authority/Industry thinking and trends, and be capable of resolving strategic technical and regulatory issues.
• Technical pharmaceutical CMC experience (laboratory, manufacturing, etc.) is desirable.
• Should demonstrate initiative, some independent thinking, anticipatory foresight, and be able to communicate effectively to internal and external audiences.
• Experience working for a Regulatory Health Authority is preferred.
• Fluency (oral and written) in English language is required.
• Potential to be able to mentor and train staff is desirable but not essential.
• This position requires minimal travel (<10%).

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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