Ideal candidate will have strong global CMC strategy background in small molecule and will work on new and the marketed products. Sterile injectables experience is preferred. Must be able to work independently and mentor the junior employees. We are also looking for expertise with direct health authority interaction. Veeva Vault experience is desirable.
Develops global regulatory CMC strategies and risk assessments for marketed 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 preparation, review and approval of regulatory CMC dossiers for submission in collaboration with, 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.
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 required.5 years of direct Regulatory CMC experience is preferred.Experience working for a Regulatory Health Authority is helpful but not essential.
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.