
Executive, Clinical and Regulatory Affairs
2 weeks ago
Responsible for activities related to the Company’s regulatory management systems, including coordinating, training, developing, improving, and implementing existing and new regulatory pathways.
- Prepares, submits, tracks, indexes and archives electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and marketing materials.
- Responsible for helping to develop and manage international product registrations, including working with the market access team to respond to requests for information, and liaise with the distributors.
- Preparing and maintaining product registration database.
- Coordinate in document legalization to support international regulatory submissions.
- Support cross functional team by contributing actively to the Clinical Evaluation Report with regular updates of the Summary of Safety and Clinical Performance, literature search, risk analysis, vigilance reporting and post-market clinical follow-up, periodic safety update reports, and post-market surveillance reports in a timely manner.
- Maintain and organize regulatory affairs files and documentation.
- Assist in implementing department procedures and provide support to Clinical and Regulatory Affairs team.
- Maintain ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file system.
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Quality Management, Regulatory Affairs
4 weeks ago
Singapore KINEXCS PTE. LTD. Full timeRoles & ResponsibilitiesKinexcs is a multidisciplinary digital health start-up at the forefront of a rapidly booming industry. It is a data-driven digital therapy platform & wearables company to enable and empower people for mobility and a better life. Kinexcs strives to enable personalised health and evidence-based recovery for musculoskeletal...
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Quality Management, Regulatory Affairs
3 days ago
Singapore KINEXCS PTE. LTD. Full timeKinexcs is a multidisciplinary digital health start-up at the forefront of a rapidly booming industry. It is a data-driven digital therapy platform & wearables company to enable and empower people for mobility and a better life. Kinexcs strives to enable personalised health and evidence-based recovery for musculoskeletal patients.Website: KinexcsJob Summary...
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Head of Regulatory Affairs
2 weeks ago
Singapore REGASK PTE. LTD. Full time**OUR COMPANY** We, at RegASK are a high growth global RegTech company leveraging technology and global network of experts to revolutionize regulatory intelligence, serving the LifeSciences (MedTech, CROs, Pharma) and FMCG industries (Food, Personal Care). RegASK team is highly diverse with more than 10 nationalities across 3 continents, entrepreneurial and...
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Regulatory Affairs
4 weeks ago
Singapore TERUMO ASIA HOLDINGS PTE. LTD. Full timeRoles & ResponsibilitiesThe role will be responsible for achieving corporate objectives and effectively ensuring that agreed strategies are implemented. Accountable for all regional and local regulations for the statutory compliance of all regulatory and QA affairs activities of the Company.A key requirement will be to balance internal ...
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Quality Management, Regulatory Affairs
7 days ago
Singapore Kinexcs Pte Ltd Full time $120,000 - $180,000 per yearKinexcs is a multidisciplinary digital health start-up at the forefront of a rapidly booming industry. It is a data-driven digital therapy platform & wearables company to enable and empower people for mobility and a better life. Kinexcs strives to enable personalised health and evidence-based recovery for musculoskeletal patients.Website: KinexcsJob...
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Drug Regulatory Affairs Specialist
2 weeks ago
Singapore DADACONSULTANTS PTE. LTD. Full time**Responsibilities**: 1. Lead Document Preparation and Submission: - Collaborate with internal teams to gather necessary documentation for IND submissions. 2. Manage Drug Registration Process: - Develop and execute regulatory strategies for drug registration submissions to health authorities. - Oversee the drug registration process, including obtaining...
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Regulatory Affairs Director
1 week ago
Singapore Solventum Full time**3M Health Care is now Solventum** At Solventum, we enable 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...
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Regulatory Affairs Director
1 week ago
Singapore NOVO NORDISK PHARMA (SINGAPORE) PTE LTD Full time**About the department** You will join our Regulatory Affairs team in Region APAC, based in Singapore. Our team is responsible for ensuring regulatory compliance for new products and product amendments, thereby keeping our license to operate. We work closely with health authorities and policymakers to shape future regulatory frameworks and ensure the safety...
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Medical and Regulatory Affairs Head
2 weeks ago
Singapore Novo Nordisk Full timeMedical and Regulatory Affairs Head **Category**:Medical Affairs **Location**:Singapore, Singapore, SG **About the department** In Novo Nordisk, the Medical and Regulatory Affairs secure the approval of new multibillion-dollar products and drug indications, making it possible for the company to bring innovative products to patients. We stand at the centre...
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REGULATORY AFFAIRS MANAGER
24 hours ago
Singapore ICM PHARMA PTE. LTD. Full timeFormulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced Oversee documentation efforts to ensure compliance with local and international regulations and standards. Develop and maintain standard operating procedures. Develop regulatory strategies and implementation plans for the...