Description
About DKSH
DKSH’s purpose is to enrich people’s lives by providing access to goods, services, and insights. United by our vision to be the trusted partner, we help companies grow in Asia and beyond across our Business Units Consumer Goods, Healthcare, Performance Materials, and Technology.
Delivering life-saving drugs to hospitals, bringing high-quality products to remote villages, installing technology that raises living standards, and providing new formulations for healthcare products that make life easier. These are just a few examples of how DKSH touches people’s lives around the clock. We do this while helping our clients and customers grow by providing services including sourcing, market insights, marketing and sales, eCommerce, distribution and logistics as well as after-sales services.
Listed on the SIX Swiss Exchange, DKSH operates in 36 markets with 33,100 specialists, generating net sales of CHF 11.1 billion in 2021. Founded by Swiss entrepreneurs in 1865, we have been deeply rooted in Asia Pacific for over 150 years.
Why It’s Great to Work at DKSH
Join a purpose-driven company and help enrich people’s lives every day. We provide reliable access to high-quality products and services, like COVID-19 vaccines, and create sustainable value for all our stakeholders, generate jobs, and give back to society. Founded over 150 years ago in Asia by three Swiss traders, DKSH still maintains the same entrepreneurial mindset. Be part of our diverse team of more than 33,000 people working in 36 markets across the globe. You will learn and develop both professionally and personally in a modern environment offering hybrid work arrangements. Come and meet our energetic, passionate, and purposeful team and be part of something big.
Create, update and maintain e-Submission Documents and/or Electronic submission such as Registration, Variations, Renewal Registration and support regulatory team to comply with the regulation including eCTD software maintenance.
Coach administration team and new staff to extend and develop their skills to be in compliance with regulation and meet business objectives.
Create regulatory database folders and maintain regulatory data to be up to date including reporting as per manager requests
Assist regulatory team on the preparation of e-Submission documents or Electronic submission package for regulatory submissions, variations and renewal activities to be completed in time.
Support regulatory team to meet and comply with the regulation including eCTD software maintenance.
Create and/or support manager to develop SOP /SD /WI for regulatory affairs.
Support regulatory team on regulatory information and other requests to succeed on product registration and business activities.
Coach administration team and new staff to expand and develop their skills to be in compliance with regulation and meet business objectives.
Arrange and maintain product registration files for each client and category and update variations into registration files when approval. Create and maintain regulatory database folders and regulatory data to be up to date including reporting as per manager requests.
Prepare and complete advertising submission, artwork review and regulatory clearance documents.
Support regulatory team on IT / CTD software maintenance and provide solutions as per manager requests.
Support regulatory team on pharmacovigilance activities.
Support regulatory team to search regulatory information and others to support projects as requested.
Risk Management
Support regulatory team to monitor and provide regulatory risk analysis or completion of regulatory requirement to meet TFDA regulation.
Support regulatory team to manage risk management or required document of client product agreed with client requirement/ PV agreement
Job Requirements:
Attention to detail & Ability to overview a task
Management of documentation skill
Computer literacy and IT management
Bachelor’s Degree (Science / Computer background)
5 years of experience in administration field.