Asia Pacific Regulatory Affairs Director
1 day ago
A. MENARINI ASIA-PACIFIC HOLDINGS PTE. LTD. is seeking a highly skilled Regional Regulatory Affairs Executive to lead our team in Asia Pacific.
About the RoleThe successful candidate will be responsible for managing the registration submissions and lifecycle of pharmaceutical products in APAC regions, including ASEAN, Greater China, Hong Kong & Macau, Taiwan, India, South Korea, Australia and New Zealand, as well as new frontier markets.
You will be the regional lead in change management and compliance, line extension projects, and regulatory viability assessments. Additionally, you will provide solutions to overcome regulatory hurdles, reduce inventory risk, and shorten dossier preparation time.
About YouTo succeed in this role, you will have at least 1 year of regional regulatory affairs experience on pharmaceuticals with track records of lifecycle and/or new registrations. You must possess a degree in Pharmacy/Pharmaceutical Sciences and have attention to details.
As a collaborative team player, you will work at a fast pace in multidisciplinary matrix organisations and adapt to IT systems to facilitate work processes.
Key Responsibilities- Regional Lead in registration submissions of pharmaceutical products in APAC regions: ASEAN, Greater China, Hong Kong & Macau, Taiwan, India, South Korea, Australia and New Zealand and in new frontier markets e.g. Maldives, Sri Lanka, etc.
- Regional Lead in change management and compliance in APAC regions
- Regional Lead in line extension projects to serve commercial marketing needs
- Assess regulatory viability of bringing EU-approved products with local regulatory colleagues through understanding the quality, non-clinical and clinical data of the products to meet country-specific requirements
- Provide solutions to overcome regulatory hurdles, reduce inventory risk and also shorten dossier preparation time so to achieve speed to market
- Artwork approver of APAC common-pack and specific-pack artworks with knowledge of labelling requirements in individual countries
- Propose best recourse of action to meet compliance requirements for legacy non-compliance issues
- Able to represent regulatory affairs in cross-functional team and manages relationships with internal stakeholders: marketing, supply chain, medical affairs, quality assurance
- Develop relationships with various partners' regulatory function stakeholders: product owners, manufacturers, distributors, external consultants
- Maintain relevant databases for registrations and status as required
- Candidate must possess at least a degree in Pharmacy/Pharmaceutical Sciences
- At least 1 year of regional regulatory affairs experience on pharmaceuticals with track records of lifecycle and/or new registrations
- Attention to details
- Ability to collaborate and work at a fast pace in multidisciplinary matrix organisations. Easily adapts to IT systems to help facilitate work processes
The estimated salary for this role is SGD $120,000 - $180,000 per annum, depending on experience and qualifications.
-
Regulatory Affairs Specialist
1 day ago
Singapore ASIA PACIFIC MEDICAL TECHNOLOGY ASSOCIATION LTD. Full timeAbout UsAsia Pacific Medical Technology Association Ltd. is a leading advocate for the medical technology industry in the Asia-Pacific region.We are seeking a highly organized and detail-oriented Regulatory Affairs Specialist to join our dynamic team.Job SummaryThe successful candidate will be responsible for monitoring regulatory developments across APAC,...
-
Associate, Regulatory Affairs
4 weeks ago
Singapore ASIA PACIFIC MEDICAL TECHNOLOGY ASSOCIATION LTD. Full timeRoles & ResponsibilitiesAbout APACMedFounded in 2014, the Asia Pacific Medical Technology Association (APACMed) is the first and only regional MedTech association in APAC, representing medical technology manufacturers (multinational corporations as well as small and medium enterprises), and local industry associations across the region. We are fully...
-
Singapore ASIA PACIFIC MEDICAL TECHNOLOGY ASSOCIATION LTD. Full timeAbout APACMedWe are the Asia Pacific Medical Technology Association (APACMed), representing medical technology manufacturers and local industry associations across the region. Our mission is to facilitate patient access to safe and high-quality medical devices, in-vitro diagnostics, and digital health products.The RoleWe are seeking a highly organized...
-
Asia Pacific Regulatory Strategy Director
3 weeks ago
Singapore SL-Human Resource Consultancy Pte Ltd Full timeJob Title: Asia Pacific Regulatory Strategy Director">Location: SingaporeDepartment: Regulatory AffairsReports to: Vice President of Regulatory AffairsAbout the Role:We are seeking an experienced and strategic Regulatory Strategy Director to join our team in Singapore. The successful candidate will be responsible for overseeing and managing all regulatory...
-
Singapore THEEXECUTIVECIRCLE ASIA PACIFIC PTE. LTD. Full timeWe are seeking a seasoned Compliance Director to lead our Regulatory and Product Safety team in the Asia Pacific region. This is a key role that will drive compliance across all product categories, ensuring we meet the highest standards of safety, environmental, and chemical regulations.The ideal candidate will have a proven track record of managing product...
-
Singapore ASIA PACIFIC MEDICAL TECHNOLOGY ASSOCIATION LTD. Full timeCompany OverviewThe Asia Pacific Medical Technology Association (APACMed) is a pioneering regional MedTech association, fostering innovative partnerships with government agencies, international organizations, and healthcare providers to facilitate patient access to safe and high-quality medical devices across the Asia-Pacific region.About the RoleWe are...
-
Regional Regulatory Affairs Executive
2 hours ago
Singapore A. MENARINI ASIA-PACIFIC HOLDINGS PTE. LTD. Full timeRoles & ResponsibilitiesPOSITION SUMMARY:The Regional Regulatory Executive will be a key member of the team responsible for new registration submission and management of product life cycle of pharmaceutical products in Asia Pacific.KEY RESPONSIBILITIES: Regional Lead in registration submissions of pharmaceutical products in APAC regions: ASEAN, Greater...
-
Financial Operations Director
3 weeks ago
Singapore Porsche Asia Pacific Full timeAbout Porsche Asia PacificPorsche Asia Pacific is a leading player in the region, with a strong presence in 13 countries. We are committed to excellence and innovation, and we're looking for talented individuals to join our team.Job SummaryWe are seeking an experienced Financial Operations Director to lead our financial functions in the Asia Pacific region....
-
Singapore GOOGLE ASIA PACIFIC PTE. LTD. Full timeJob OverviewWe are seeking an experienced Asia Pacific Government Affairs and Public Policy Specialist to join our team in GOOGLE ASIA PACIFIC PTE. LTD.Estimated Salary: SGD 120,000 - 180,000 per annumAbout the RoleThis role will be based in APAC region and will focus primarily on the Japan market. You will work closely with the broader Government Affairs...
-
Singapore PERSOLKELLY SINGAPORE PTE. LTD. Full timeJob OverviewPersolkelly Singapore Pte Ltd is seeking a highly skilled Regulatory Affairs Senior Specialist to join our team in expanding our presence in the Asia Pacific market. As a key member of our regulatory affairs team, you will be responsible for leading projects related to product registrations and renewals, ensuring compliance with local...
-
Asia Pacific Corporate Affairs Manager
3 weeks ago
Singapore KPMG - Singapore Full timeRole OverviewWe are seeking a highly skilled and experienced Asia Pacific Corporate Affairs Manager to join our dynamic KPMG Asia Pacific Team in Singapore. This role presents an exciting opportunity to build relationships with senior leaders across member firms throughout the Asia Pacific region and beyond.
-
Senior regulatory affairs specialist
2 weeks ago
Singapore Airswift Full timeSenior Regulatory Affairs Specialist (1-Year Contract) Location: Singapore (On-Site) We are seeking a Senior Regulatory Affairs Specialist to join a dynamic global healthcare organization specializing in innovative diagnostic solutions. This role focuses on regulatory submissions and license management across high-growth markets in the Asia-Pacific region....
-
Singapore Eli Lilly And Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Singapore BEATHCHAPMAN (PTE. LTD.) Full timeCompany Overview:BeathChapman Pte Ltd, a leading Asian Pharma company, is embarking on its second phase of growth in Singapore. As a key player in the market, they are seeking a highly skilled Regulatory Affairs Manager to spearhead registration approvals across Southeast Asia.
-
Regulatory Affairs Director, Asia Pacific
3 weeks ago
Singapore SL-Human Resource Consultancy Pte Ltd Full timeSL-Human Resource Consultancy Pte Ltd is seeking an experienced Regulatory Affairs Director to join our team in Singapore.About the RoleThis strategic leadership position plays a vital role in overseeing and managing all regulatory activities, ensuring compliance with local and international regulations, and driving regulatory strategy to support business...
-
Singapore ASIA PACIFIC EXCHANGE PTE. LTD. Full timeJob SummaryWe are seeking a highly experienced and skilled Strategic Financial Director to lead our Finance Department in the Asia Pacific region. The successful candidate will be responsible for driving financial planning, managing day-to-day operations, and reporting financial results to our board of directors and shareholders.
-
Singapore NTT ASIA PACIFIC PTE. LTD. Full timeAbout the RoleWe are seeking an exceptional Director of Digital Transformation in Asia Pacific to join our team at NTT ASIA PACIFIC PTE. LTD.This is a senior leadership role that requires a strategic thinker with extensive experience in driving digital transformation programs and initiatives.Key ResponsibilitiesDevelop and implement strategic plans and...
-
Senior Specialist, Regulatory Affairs
1 week ago
Singapore INTERNATIONAL FLAVORS & FRAGRANCES (GREATER ASIA) PTE. LTD. Full timeRoles & ResponsibilitiesJob SummaryThis position will be responsible for the management of product registrations, product compliance or product safety and risk assessment for Animal Nutrition & Health. IFF applies expert science to advance market-driven, healthy, and sustainable solutions for the food/feed, beverage, dietary supplements, and many other...
-
Singapore Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Medical Devices Director
2 weeks ago
Singapore SL-Human Resource Consultancy Pte Ltd Full timeJob Title:Medical Devices Director - Asia PacificOverviewWe are seeking a seasoned Medical Devices Director to lead our business in the Asia Pacific region. As a key member of our team, you will be responsible for driving growth and profitability in this dynamic market.Salary:The estimated salary for this position is between SGD 180,000 to SGD 250,000 per...