JOB PURPOSE:
• To create, standardize and implement of system to monitor regulatory policy or policy in its formative stages for relevance and impact to company’s internal processes, drug development and or regulatory and corporate strategies with coordinating regulatory team and cross functions (as needed)
• To make assessment and summary on important regulation monthly, working collaboratively with internal stakeholders
• To coordinat developing policy positions for external influence, Cooperatively within Sanofi create and execute advocacy strategies to achieve policy goals.

KEY ACCOUNTABILITIES:

· Monitor regulation
• Creation, standardization and implementation of systems/processes to monitor the regulatory regulatory policy or policy in its formative stages for relevance and impact to company’s internal processes, drug development and or regulatory and corporate strategies; while work closely with excellence colleagues to ensure the regulation interpreted effectively into the daily regulatory work.
• Exchange information and related news from association e.g. RDPAC etc.

· Assessment and Summarize monthly for important regulation
• Leverage team’s assessment of regulation and brief summary for all important regulation monthly
• Periodically draft roundup regulation slides
• Edit all related Newsletter (e.g. Highlight/RND newsletter/RSP newsletter Policy to ExCome, etc.).


· As coordinator to lead regulation and policy commenting and assessments
• Internal coordination on regulation as DAL, DRR and assigned topics leaders
• Organize Policy Committee meeting and coordinate subgroup of COE & CMC.
• Attend global RSP group meeting, exchange information, contribute as window person, e.g. ICH survey, CIRS and bring back for sharing in team


· Coordination and Management on regulation position paper
• Management on Critical Topics and position paper collection.
• Coordinate comments on position if possible from Epifia, PhRMA etc.
· Act consistently with Sanofi best practices and code of ethic


JOB-HOLDER ENTRY REQUIREMENTS:
· Master degree or above in Life Science, Pharmacy, Medical, Biology or related field (Bachelor acceptable in special cases)
• 5+ years’ RA or RI experience and 6 years’ industry experience is plus.
• Extensive and proven expertise in Regulatory environment in healthcare is plus.
• Good Track record; independent working; experience working in trade associations or other key groups that influence regional policies is plus.

Core competencies：
• Good computer skill in EXCEL, POWERPOINT and WORD;
• Excellent interpersonal and communication/presentation skills；
• Chinese and English (proficiency level) skill both in spoken and written;

其他信息
语言要求：英语、普通话