Regulatory affairs specialist
2 weeks ago
Regulatory Affairs Specialist (Pharmaceutical/ Medical Devices) GENERAL SUMMARY OF ROLE: This role will be responsible for all the domestic and regional regulatory affairs (RA), including but not limited to NDAs, variations and registration renewals in Singapore and Asian countries. She (or he) shall also be responsible for establishing domestic and regional pharmacovigilance for the products. Responsibilities: Responsible for the preparation and documentation of regulatory submissions to government agencies. Works on problems of diverse scope where analysis of situations or data requires a review of identifiable factors. Exercises judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Normally receives no instructions on routine work, general instructions on new assignments. May provide leadership by assigning work and resolving complex problems. With direction, develops plans for regulatory strategies. Participates in project team meetings and provides regulatory advice. Seeks solutions and alternatives to problems and issues. Prepares regulatory documents for regional submissions. Acquires information from appropriate technical groups and project personnel which addresses performance of diagnostic reagents, instruments, and software. Assures adequate documentation exists for product claims and directs timely review of regulatory documents. Acts as a liaison for international divisions by tracking requests for information and monitoring international laws. Provides product performance data as requested by international personnel and other corporate groups. Monitors FDA and other agency laws and regulations, and provides recommendations and assistance to ensure company compliance. Direct certification application activities including sending and tracking certification letters. Maintain tracking log, and supply global registration requests. Provides metrics for regulatory management reporting and helps to identify areas for further monitoring for global product development system (GPDS) improvements. Track global registration status for project teams and new products. Log, track, and prepare report from e GPS system. Brings Regulatory Affairs questions/issues to the attention of RA management. Preparing responses to agency's questions with good writing and communication skills. Performs other related duties and assignments as required. EDUCATION AND EXPERIENCE: Min Degree in any science related field Minimum 2 - 3 years of experience in either domestic and regional regulatory affairs would have an advantage Familiar with regulatory affairs such as NDA, variation and renewal of product registrations in Pharmaceutical industry (manufacturer or distributor) would be at an advantage Pharmacovigilance (or safety monitoring/reporting) experiences preferred but not mandatory SKILLS/KNOWLEDGE/ABILITIES/BEHAVIOUR TRAITS: Project strong initiatives to establish the operating procedures for a new start-up organization. Strong communication and interpersonal skill in shared office environment. Pro-active and positive mindset Able to prioritize tasks and workload #J-18808-Ljbffr
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Regulatory Affairs Specialist
4 weeks ago
Singapore HAYS SPECIALIST RECRUITMENT PTE. LTD. Full timeJob Title: Regulatory Affairs SpecialistThe company is a fast-growing food and beverages business with a strong presence across Asia.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with all applicable laws and regulations.Stay up-to-date on changes in regulatory requirements and translate them into actionable steps for...
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Global Regulatory Affairs Director
3 weeks ago
Singapore HAYS SPECIALIST RECRUITMENT PTE. LTD. Full timeRegulatory Affairs Lead - SingaporeHAYS SPECIALIST RECRUITMENT PTE. LTD.About the CompanyHAYS SPECIALIST RECRUITMENT PTE. LTD. is a leading recruitment agency in Singapore, specializing in placing top talent in various industries. As a pioneer and growing team, we offer regional exposure, fast-track career progression into management, and exciting...
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Regulatory Affairs Director
4 weeks ago
Singapore HAYS SPECIALIST RECRUITMENT PTE. LTD. Full timeAbout the RoleWe are seeking a highly experienced Regulatory Affairs Lead to join our team in Singapore. The ideal candidate will have at least 5 years of experience in food regulatory affairs management, preferably with expertise in AMER or EMEA region.The successful candidate will be responsible for developing and implementing regulatory strategies to...
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Regulatory affairs specialist
2 weeks ago
Singapore PSA International Full timeJob Title: Regulatory Affairs Specialist The company is a fast-growing food and beverages business with a strong presence across Asia. Key Responsibilities: Develop and implement regulatory strategies to ensure compliance with all applicable laws and regulations. Stay up-to-date on changes in regulatory requirements and translate them into actionable steps...
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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...
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Senior Specialist, Regulatory Affairs
4 weeks 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...
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Regulatory Affairs Specialist
3 weeks ago
Singapore MTC CONSULTING PTE. LTD. Full timeJob Description:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at MTC Consulting Pte Ltd.About the Role:This is an exciting opportunity for a talented professional to play a key role in ensuring compliance with regulatory requirements for medical devices.About the Company:MTC Consulting Pte Ltd is a leading consulting firm...
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Senior regulatory affairs specialist
1 month 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....
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Regulatory Affairs Specialist
4 weeks ago
Singapore MTC CONSULTING PTE. LTD. Full timeWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at MTC Consulting Pte Ltd.Company OverviewMTC Consulting Pte Ltd is a leading consulting firm that provides expert advice on regulatory affairs in the medical devices industry. We are committed to helping our clients navigate the complex regulatory landscape and stay ahead of the...
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Regulatory Affairs Specialist
4 weeks ago
Singapore MTC CONSULTING PTE. LTD. Full timeCompany OverviewMTC Consulting Pte Ltd is a leading provider of consulting services for medical devices and life sciences technology.SalaryThe estimated salary for this role is $4,500 + completion bonus, with the potential for conversion to a permanent role. This offer is based on industry standards in Singapore and the specific requirements of the...
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Regulatory Affairs Specialist
3 weeks ago
Singapore NYPRAX PHARMA PTE. LTD. Full timeJob OverviewWe are seeking an experienced Regulatory Affairs Manager to join our team at NYPRAX PHARMA PTE. LTD.This is a challenging role that requires strong regulatory knowledge and excellent communication skills.The successful candidate will be responsible for coordinating and submitting documentation to the Health Sciences Authority, compiling client...
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Singapore INTEGRITY PARTNERS PTE. LTD. Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at INTEGRITY PARTNERS PTE. LTD.This 6-month contract position involves assisting in the execution of regulatory strategies for medical devices across various markets, with a focus on efficient pre-market and post-market approvals.
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Regulatory Affairs Specialist
3 weeks 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,...
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Apac regulatory affairs specialist
2 weeks ago
Singapore Lesaffre Iberica SA Full timeAt Gnosis by Lesaffre, we harness the power of microorganisms to transform compounds into usable nutritional actives, probiotics, and nutritional and functional yeasts that benefit human wellbeing. We strive to create a world that moves better, digests better, ages better, feels better, and ultimately, lives better thanks to microorganisms and...
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Apac regulatory affairs specialist
2 weeks ago
Singapore Lesaffre Singapore Full timeAbout Gnosis by Lesaffre At Gnosis by Lesaffre, we harness the power of microorganisms to transform compounds into usable nutritional actives, probiotics, and nutritional and functional yeasts that benefit human wellbeing. We strive to create a world that moves better, digests better, ages better, feels better, and ultimately, lives better thanks to...
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Clinical Regulatory Affairs Specialist
3 weeks ago
Singapore GWIA PTE. LTD. Full timeJob OverviewWe are seeking a highly skilled Clinical Regulatory Affairs Specialist to join our team at GWIA PTE. LTD.About the RoleThis is a $80,000 - $100,000 per year opportunity for a motivated and experienced professional to lead medical affairs initiatives and drive business growth.Key ResponsibilitiesThe successful candidate will be responsible...
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Senior Regulatory Affairs Specialist
3 weeks ago
Singapore MORGAN PHILIPS SINGAPORE PTE. LTD. Full timeCompany Overview:Morgan Philips Singapore Pte. Ltd. is a leading medical device company dedicated to advancing healthcare through innovative solutions.Job Summary:We are seeking a Senior Regulatory Affairs Specialist to join our team in Singapore. This role will involve managing compliance programs and providing regulatory guidance on matters related to...
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Regulatory Affairs Specialist
4 weeks ago
Singapore RANDSTAD PTE. LIMITED Full timeAbout RANDSTAD PTE. LIMITEDOur client is a world-class MNC Healthcare company, specializing in Innovative Medicine and MedTech. They empower themselves to tackle global health challenges through innovation and technology, ultimately transforming patient care.SalaryThe estimated salary range for this role is SGD $60,000 - SGD $80,000 per annum, depending on...
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Food Regulatory Affairs Manager
3 weeks ago
Singapore HAYS SPECIALIST RECRUITMENT PTE. LTD. Full timeYour new roleBelow are some of the key responsibilities for this position:• Develop and implement strategic plans to ensure regulatory compliance with all applicable laws and regulations.• Stay up-to-date on changes in regulatory requirements and translate them into actionable steps for the organization.• Lead a team of regulatory professionals,...
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Regulatory Affairs Specialist
3 weeks ago
Singapore OASIS BIO PTE. LTD. Full timeOASIS BIO PTE. LTD. is seeking a highly skilled Regulatory Affairs Specialist to join our team in Singapore. As a key member of our regulatory affairs department, you will be responsible for managing the drug registration process for our innovative pharmaceuticals across Southeast Asia, with a primary focus on Singapore and Malaysia.About the RoleIn this...
