Internal Job Description **JOB DESCRIPTION** **_(Associate Regulatory Manager)_** **JOB PURPOSE:** • Be accountable for implementing regulatory strategy to obtain the regulatory approval to support various development, manufacturing, sales and marketing activities for the designated product group • Support line Manager for the HA interaction for the strategy discussion and be accountable for the HA interaction to facilitate the implementation process **KEY ACCOUNTABILITIES:** ● **Be accountable for implementing regulatory strategy to obtain the regulatory approval to support various development, manufacturing, sales and marketing activities for the designated product** • Lead the submission for the responsible projects or tasks with the guidance of senior regulatory manager • Collaborate with related functiona at corporate, IA and work with affiliates to support the regulatory activities in the region • Ensure the high-quality submission with effective communication with agency and internal stakeholders/peers for the assigned projects/tasks ● **Suppoert Line Manager or Submission Team leader for the regulatory strategy assessment** • Work with related functions at GRA and China region to develop and implement the regulatory strategy of the responsible projects for the region, aligned with global strategy and regional business strategy • Work across project team and related workstreams to evaluate, Dossier 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. • Provide the Inputs for strategic projects on RA regulations, requirements, trends • Provide regulatory intelligence collection and analysis ● **Provide Regulatory support to cross-functions to ensure business success** **Ensure regulatory compliance and work in compliance way** **JOB-HOLDER ENTRY REQUIREMENTS:** **Education:** • Master degree or above in Pharmacy, Medical, Biology or related field (Bachelor acceptable in special cases) **Experience & knowledge:** • Mimimal 3 years+ RA experience along with 5 years industry working experience with track record performance in obtaining regulatory approval **Core competencies:** • Good computer skill in EXCEL, POWERPOINT and WORD; • Good interpersonal communication skill • Chinese and English (proficiency level) skill both in spoken and written **Pursue** **_progress_** **, discover** **_extraordinary_** Better 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. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)