Associate Director Regulatory CMC
Waltham, Massachusetts, Bridgewater, New Jersey
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Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
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Develops global regulatory CMC strategies and risk assessments for development projects and/or marketed products (new or marketed chemical entities, biological entities, vaccines and/or consumer health care products) 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. 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. 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.
Knowledge, Skills & Competencies:
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.
Should demonstrate initiative, some independent thinking, anticipatory foresight, and be able to communicate effectively to internal and external audiences.
Fluency (oral and written) in English language is strongly recommended.
Potential to be able to mentor and train staff is desirable but not essential.
Minimum of a Bachelor’s Degree; advanced degree (Masters, PhD) in a science/health field (eg, Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalent, is desirable.
Technical pharmaceutical CMC experience (laboratory, manufacturing, etc.) is desirable. Typically, an additional 1-5 years of direct Regulatory CMC experience is preferred. However more than 5 years may be applicable for certain associates within an individual contributor career path. Experience working for a Regulatory Health Authority is helpful but not essential.
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.
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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