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Manager Regulatory Affairs
1 month ago
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.
Job Summary
Dossier review and regulatory evaluation for new projects/products.
Develop and implement registration strategies and action plan of new registrations for responsible products.
Support responsible countries in APAC for product registrations and related regulatory activities. General Responsibilities
Develop and implement registration strategies and action plan of new registrations for responsible products.
Dossier review and regulatory evaluation for new projects/products.
Support responsible countries for product registrations and related regulatory activities.
Act as primary liaison with local regulatory affairs personnel on Regulatory Affairs issues.
Manage the review with local regulatory affairs personnel on Regulatory Affairs' activities and updates to obtain commitment on local regulatory affairs implementation.
Compilation of registration documentation in co-operation with supplier/manufacturers.
Maintenance of RA database of master dossiers, registration status and regulatory requirement.
Maintenance of registration life-cycle of existing products.
Work closely with regional marketing, supply chain and manufacturers to ensure smooth logistic flow. Functional Skills and Knowledge
Demonstrate knowledge in quality assurance tools, concepts and methodologies
Demonstrate good knowledge of regulatory requirement and regulatory compliance of healthcare products.
Demonstrate basic understanding of the Global Harmonized System (GHS), especially ASEAN Harmonization of Healthcare product registrations.
Demonstrate proficiencies in office productivity tools (e.g. Excel, Word and PowerPoint).
Demonstrate appreciation and respect for cultural sensitivities especially in cross-country/-cultural interactions.
Demonstrate fluency in English, both written and spoken. Education
Bachelor’s Degree or higher in Pharmaceutical Sciences or related field. Work Experience
8-10 years-experiences in regulatory affairs of pharmaceutical, medical devices, cosmetics & related healthcare products.
Preferable regional experiences
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