Regulatory affairs manager
18 hours ago
Position: REGULATORY AFFAIRS MANAGER (1 vacancy - immediate) Job Description (all processes will be taught in-house): Co-ordination and online submission of various formatted documentation to the Health Sciences Authority (Ministry of Health) Compiling of client's dossiers for medical devices and applications as per Ministry's requirements Formatting of medical dossiers documents Checking for accuracy in verification and validation of reports Responding to Ministry queries when necessary Able to work under pressure, multi-task and detail-oriented Filing & Ad-hoc duties Keen attitude towards learning and able to meet timelines Strong commitment and willingness to learn and grow with the company Requirement: Preferably Degree holders with at least 2 years of experience in Regulatory Affairs for Medical Device / Pharmaceutical in Singapore / Southeast Asia (more than 1 country would be preferred) Required language(s): English Required Skill(s): Good command of computer Skills, Microsoft Office Good aptitude to learning in a challenging Healthcare Industry All processes will be taught in-house and to show ability to have a good grasp of handling these processes Why Join Us: Network: Nyprax works with a vast network of medical devices and IVD clients worldwide, from MNCs to SMEs. Working Hours: Mondays – Fridays, 9am – 6pm Work Location: 116 Changi Road, #04-05 , Singapore 419718 Nearest MRT station: Eunos Station or Bus Interchange. 5-7 minutes’ walk to office Remuneration: Candidate can expect attractive remuneration with good KPI bonuses Environment: Friendly working environment with good training provided Company Overview: Nyprax Pharma is a rapidly expanding Regulatory Affairs Consultancy firm. With over 20 years of experience in the field of Regulatory compliance, we offer expert guidance and consultation ensuring smooth submissions to meet the local regulatory requirements so as to enable your medical device to be imported, distributed and marketed in Singapore. COMPENSATION: MID - CAREER INDIVIDUALS: S$ 4500/MONTH - starting salary Career growth is dependent on personal aptitude and ambition Contact: Bharat Kumar ( ) #J-18808-Ljbffr
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Regulatory Affairs Coordinator
2 weeks ago
Singapore EPIC MEDICAL PTE. LTD. Full timeRegulatory Affairs InternshipEPIC MEDICAL PTE. LTD. is seeking a highly motivated and detail-oriented individual to join our Regulatory Affairs team as a Regulatory Affairs Intern.This exciting opportunity will provide the chance to gain hands-on experience in the preparation, submission, and monitoring of regulatory documents for healthcare/medical...
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Regulatory Affairs Intern
3 weeks ago
Singapore EPIC MEDICAL PTE. LTD. Full timeRoles & ResponsibilitiesJob Description: Regulatory Affairs InternLocation: SingaporeDepartment: Regulatory AffairsDuration: 6 monthsPosition Overview:We are seeking a highly motivated and detail-oriented intern to join our Regulatory Affairs team. As a Regulatory Affairs Intern, you will have the opportunity to gain hands-on experience in the preparation,...
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Regulatory Affairs Manager
1 week ago
Singapore Innomar Strategies Full timeAbout UsInnomar Strategies is a leading provider of healthcare solutions. We are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Coordinate and compile regulatory submissions, responses to agency questions,...
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Project Manager, Regulatory Affairs
2 months ago
Singapore PRESTIGE BIOPHARMA LIMITED Full timeRoles & ResponsibilitiesJOB FUNCTIONProject Manager, Regulatory AffairsMAIN RESPONSIBILITIES· Manage project submissions as assigned by Regulatory Affairs leadership· Support the management of key projects, including execution, for submission, approval, and launch· Review, prepare and author documents for regulatory submissions including clinical trial...
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Associate, Regulatory Affairs
4 days 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...
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Regulatory Affairs Director
3 weeks ago
Singapore ABIORES PTE. LTD. Full timeRoles & ResponsibilitiesJob Description:- Develop and implement regulatory strategies to secure product approvals more quickly than competitors.- Lead complex decision-making processes among stakeholders and senior leadership in a dynamic regulatory environment.- Provide expert advice on regulatory strategy, Health Authority engagement, and submission...
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Regulatory Affairs Manager
3 weeks ago
Singapore EPS COMPUTER SYSTEMS PTE LTD Full timeRoles & ResponsibilitiesJob PurposeThe Regulatory Affairs Manager will :- Support the Marketing Authorisation transfer activities for GRA in Asia Pacific (APAC). Support the APAC distributors and regulatory consultants with the assigned GRA activities for APAC. Support the regulatory CMC activities (and strategy as needed) for assigned product(s) in APAC....
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Regulatory affairs coordinator
1 week ago
Singapore ResMed Inc Full timeRegulatory Affairs Coordinator Location: Singapore, Singapore Time Type: Full time Posted on: 5 Days Ago Job Requisition ID: JR_035534 The Regulatory Affairs Coordinator supports the regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices. This position involves assisting in the preparation of...
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Regulatory affairs coordinator
1 week ago
Singapore ResMed Inc Full timeRegulatory Affairs Coordinator Apply to locations: Singapore, Singapore Time type: Full time Posted on: 6 Days Ago Job requisition id: JR_035534 The Regulatory Affairs Coordinator supports the regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices. This position involves assisting in the...
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Regulatory Affairs Director
2 weeks ago
Singapore ABIORES PTE. LTD. Full timeJob Title: Senior Regulatory StrategistRegulatory Affairs at ABIORES PTE. LTD.At ABIORES PTE. LTD., we are seeking an experienced Senior Regulatory Strategist to lead our regulatory affairs efforts. As a key member of our team, you will develop and implement regulatory strategies to secure product approvals quickly and efficiently.Key Responsibilities:•...
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Regulatory Affairs Specialist
2 weeks ago
Singapore IQVIA Full timeKey Responsibilities:Deliver regulatory projects on time and with a proactive approach, coordinating with in-country regulatory team leads.Core Competencies:Identify and interpret regulations, guidelines, and other pertinent information issued by regulatory agencies.Review scientific data, publications, and related papers to ensure compliance with...
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Regulatory Affairs Executive
2 months ago
Singapore ITS SCIENCE & MEDICAL PTE LTD Full timeRoles & ResponsibilitiesJOB SUMMARYThe Regulatory Affairs Executive will play a critical role in ensuring that the company's products comply with all required national and international regulations and standards. This position involves working closely with various external regulatory authorities and stakeholders, and internal departments to provide expertise...
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Regulatory Affairs Director, APAC
2 weeks ago
SG, SINGAPORE, VIRTUAL Solventum Full timeRole Overview:As the Regulatory Affairs Director for Solventum, you will lead the APAC Regulatory Affairs team, playing a critical strategic role in ensuring compliance and driving business success. Your expertise will be essential in developing and executing regulatory strategies to achieve product approvals faster than competitors.Key...
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Regulatory Affairs Specialist
2 weeks ago
Singapore BEATHCHAPMAN (PTE. LTD.) Full timeWe are seeking an IVD product registration expert for a company specializing in the IVD space. This position will primarily focus on registering products in SEA and globally.The Regulatory Affairs Specialist will be responsible for:Reviewing current product approvals and registrations to assess the state of the SEA business.Working with the commercial team...
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Regulatory affairs lead
18 hours ago
Singapore HAYS SPECIALIST RECRUITMENT PTE. LTD. Full timeYour new company Our client is a fast-growing food and beverages company, with a strong presence across Asia. They are looking for an experienced Regulatory Affairs Lead to help them grow their regulatory team here in Singapore. Your new role Below are some of the key responsibilities for the role: Develop and implement regulatory strategies to ensure...
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Senior regulatory affairs executive
6 days ago
Singapore SG Diagnostics Full timeCommunicate with regulatory bodies on regulatory affairs (e.g. product registration, change notifications) Communicate with team members on required regulatory requirements during product development Dossier preparation and submission for product registration Support post-market activities (e.g. customer complaint, post-market surveillance, adverse events,...
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Regulatory Affairs Director, APAC
4 weeks ago
SG, SINGAPORE, VIRTUAL Solventum Full timeJob Title: Regulatory Affairs Director, APACAt Solventum, we are seeking a highly skilled and experienced Regulatory Affairs Director to lead our APAC Regulatory Affairs team. This role will be responsible for developing and executing regulatory strategies to achieve product approvals faster than competitors.The Impact You'll Make in this RoleDevelop and...
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Senior Manager, Global Regulatory Affairs Lead
2 weeks ago
Singapore Mondelēz International Full timeAbout This RoleWe are seeking a Senior Manager, Global Regulatory Affairs Lead to join our team at Mondelēz International. As a key member of our regulatory affairs team, you will be responsible for developing and executing our regulatory strategy for South East Asia.Key ResponsibilitiesDevelop and execute the regulatory affairs strategy for South East...
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Lead Regulatory Affairs Strategist, APAC
24 hours ago
SG, SINGAPORE, VIRTUAL Solventum Full timeOverviewSolventum is a pioneering healthcare company that creates innovative solutions to improve lives. As a leading manufacturer of medical devices, we partner with the brightest minds in healthcare to deliver breakthrough products that change patients' lives for the better.Job DescriptionWe are seeking an experienced Regulatory Affairs Director to lead...
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Regulatory Affairs Director, APAC
1 month ago
SG, SINGAPORE, VIRTUAL Solventum Full timeJob Description:Solventum is a pioneering company that enables better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material, and data science that change patients' lives for the...