Regulatory strategy establishment for new vaccines and the regulatory strategy implementation by CTA / NDA submission / approval.
● Work with GRA and across project team to develop and implement the regulatory strategy of the responsible projects, aligned with global strategy and regional business strategy. (Dossier preparation, gap assessment, regulatory pathway and timelines, RA compliance, Implication of the findings on the deal terms, ways to mitigate identified risks, implications on cost / time etc.)
● Regulatory supports for the related submissions in China region
● Collaborate with related functiona at corporate, IA and project team to support the regulatory activities in China region.
● Effective interaction with Health Autorities.
● Lead the cooperative projects related to shaping of registration regulatory environment.
● Lead and coordinate the HA interaction and cross-functional discussion & contribution.
● Provide RA inputs
● Move forward the projects in agreed timetable.
● Provide RA supports on vaccine China business
● Work with related functions in China to provide RA support on business timely.
● Update key changes in regulations and their implications
● Inputs for strategic projects on RA regulations, requirements, trends.
● Ensure regulatory compliance and work in compliance way
Job Family Group: Regulatory Affairs - Center of Expertise
Pursue progress, discover extraordinaryBetter 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.
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Skills Required
- Experience in regulatory affairs, preferably in vaccines
- Knowledge of regulatory requirements in China
- Excellent communication and interpersonal skills
- Ability to work collaboratively in a cross-functional team
Sanofi Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sanofi and has not been reviewed or approved by Sanofi.
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Retirement Support — Retirement support stands out through a notably strong 401K matching structure (e.g., 150% match up to a 6% contribution), which materially boosts total rewards for long-tenured employees.
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Parental & Family Support — Parental and family support is positioned as unusually robust, including a global gender-neutral paid parental leave standard (14 weeks) and added supports such as childcare assistance and adoption/surrogacy/infertility help.
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Equity Value & Accessibility — Equity participation is made more accessible via an Employee Stock Purchase Plan that includes a meaningful purchase discount and matching/free-share mechanics, increasing perceived total compensation beyond base pay.
Sanofi Insights
What We Do
We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Interactions with this account must comply with the Terms: https://bit.ly/sanofi-terms
