Regulatory Affairs Consultant
Description
When our values align, there's no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Key Accountabilities:Main ResponsibilitiesResponsible to establish and maintain a group of high performing regulatory affairs professionals working in an efficient, productive and harmonized fashion to support the execution of company plans in Hong Kong.Closely collaborate with regional regulatory expertise in the Therapeutic Areas in both labelling and CMC aspects.Design, deploy and maintain processes and/ or systems to manage external stakeholders, of which includes local change implementation management. External stakeholders include, but not limited to, provision of documents and liaison with local third party, government tendering bodies, Hospital Authority, etc.Provide regulatory support, including oversight of product launch and implementation timelines to internal and external stakeholder.Accountable for planning, leading and delivering Hong Kong registration strategies across a broad range of company products, while ensuring alignment --- Source: jobicy - Parexel
