Provide Regulatory input to Global Regulatory Affairs on local RA strategy, liase with Commercial
Ensure adequate process flow for the dossiers to support regional business goals, optimum yearly targets and registration plans.
Interact with and support BU management, sales & medico-marketing group for the preparation of market plans and direction to be undertaken by HQ.
Become an expert of Asia regulatory requirements and provide clear guidance to company stakeholders related to any potential impact on product registration and maintenance.
Coordination of regulatory activities between source contact & RA Affiliates to ensure availability of the dossier / additional data and find appropriate ways to facilitate and accelerate product registration.
Monthly report to reflect Regulatory Affairs activities
Planning for tracking submissions by RA Affiliates / estimated & effective approval dates
Development and implementation of standard operating procedures related to regulatory affairs
Provide Regulatory expertise on external growth opportunities (DD) and for each project ensure adequate regulatory resources for dossier assessment, coordinate regulatory activities with RA Affiliates, source contact and other relevant functions.
Identify regulatory issues and ensure resolution in a timely fashion with adequate planning.
Provide effective communication to functional, regional organizations and project team members.
Identify and work closely with internal and external experts to achieve optimal outcomes.
Develop strong partnership with other departments, i.e.: Patent, Public Affairs, Industrial Affairs, BD, Legal, Finance, Medical, Pharmacovigilance, supply chain, marketing, etc.
Experience & Skills
Degree in Pharmaceutical Sciences/ Life Sciences/ Bio-medical sciences
At least 5 years of experience including internships in regulatory CMC/ Regulatory affairs in regulated or lesser regulated markets.
Highly self-motivated, Pro-active, responsible and autonomy.
Strong interpersonal and communication skills and fluency in English
Well-organised with good sense of responsibility.
Computer skills: Word, Excel, On-line (Quest 2) Registration.
Prior experience in Asia regulatory affairs would be an advantage.
Strong organizational, negotiation and influencing skills
Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.
At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.