Regulatory Affairs Consultant
Parexel
full-time
Posted on:
Location Type: Remote
Location: Hong Kong
Visit company websiteExplore more
About the role
- Responsible 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.
- 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.
Requirements
- 5 years of experience in the Hong Kong pharmaceutical industry; biologics regulatory experience preferred.
- Proficiency in PRS2.0
- Experience of strategic leadership across product development and commercialisation lifecycle with examples of contribution.
- Experience in building high performing RA teams and effective delivery of objectives in a complex matrix environment.
- Fluent in Cantonese and English.
Benefits
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory affairsproduct launchregistration strategiesbiologics regulatory experiencestrategic leadershipproduct developmentcommercialisation lifecycleteam buildingprocess designstakeholder management
Soft Skills
collaborationcommunicationleadershiporganizational skillsproblem-solvingadaptabilityefficiencyproductivityharmonizationdelivery of objectives