Regulatory Affairs Specialist
2 days ago
The company I’m representing is a leading consumer healthcare MNC with a good presence globally. They are looking for a Regulatory Affairs Specialist to help with their product registrations across the ASEAN region. This incumbent would have opportunities for career progression internally.
**Responsibilities**:
- To prepare and track overall regulatory projects & timelines to monitor potential bottle necks in registration matters and to assist in developing or improving submission strategies.
- To communicate with internal & external stakeholders on documentation requirements for regulatory submissions of new/ existing products; to review and compile dossier package before official submission.
- To perform labelling checks and highlight discrepancies against stipulated label requirements of the respective import & export country and/or inconsistency with other markets.
- To research and obtain regulatory information from Authorities for new/existing countries and present findings and recommendation to the top management and relevant stakeholders.
**Job Requirements**:
- A good Degree in Chemistry/Pharmacy/Microbiology/Science.
- Minimum 2 years of relevant working experience in Regulatory environment for health product or OTC pharmaceutical products.
- Familiar with ASEAN regulatory guidelines.
- Singaporeans/PRs only as the company does not have foreign quotas
CEI: R22106296 | Licence No: 19C9622
**Salary**: $3,500.00 - $4,500.00 per month
Schedule:
- Monday to Friday
Supplemental Pay:
- 13th month salary
- Performance bonus
- Yearly bonus
**Education**:
- Bachelor's or equivalent (required)
-
Regulatory Affairs Specialist
7 days ago
Singapore Johnson & Johnson Full timeCaring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of...
-
Regulatory Affairs Specialist
4 days ago
Singapore ALCOTECH PTE. LTD. Full time**Alcotech Pte Ltd**specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia. **Role Overview**: **Key Responsibilities**: - Prepare, review, and submit medical device registration dossiers...
-
Regulatory Affairs Specialist
6 days ago
Singapore MERIT MEDICAL SINGAPORE PTE. LTD. Full time**PURPOSE OF JOB** Subject matter expert in determining the current regulatory requirements and strategies for Merit Medical Singapore design control projects. Prepare documents and /or submission required to obtain clearance or approval from government agencies for commercial distribution of Merit’s Medical Devices. Key government agencies with direct...
-
Specialist, Regulatory Affairs
6 days ago
Singapore MSD Full time**Specialist, Regulatory Affairs** **THE OPPORTUNITY** - Based in Singapore, top-ranked biopharmaceutical company on The Straits Times and Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021). - Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years. Our...
-
Junior Regulatory Affairs Specialist
4 days ago
Singapore Andaman Medical Full timeWe are looking for a Regulatory Affairs Specialist with at least 1 year experience in medical devices and or any related field, who can further assist our team in Thailand in processing medical device registration, determining risk classifications of health products and monitoring trends regarding the industry regulations. - Preparing and submitting...
-
Specialist, Regulatory Affairs
2 weeks ago
Singapore ResMed Full time $80,000 - $120,000 per yearAbout ResMedAt ResMed, we pioneer innovative health technologies that transform millions of lives daily. From connected respiratory care to cloud-based software solutions, our devices span the globe and connect patients, providers, and data to improve healthcare outcomes. We are proud to lead in the medical device space, where quality, compliance, and...
-
Quality and Regulatory Affairs Specialist
6 days ago
Singapore MAJETON PTE. LTD. Full timeRoles & Responsibilities At Majeton, we are driven by our commitment to deliver “The Right Product for Health”. Our team of researchers and clinical experts utilize clinic feedback from practitioners, scientifically researched literature and top quality manufacturing as the foundation for all products. We are seeking a meticulous and experienced Quality...
-
Regulatory Affairs Specialist
1 week ago
Singapore AITBIOTECH PTE. LTD. Full time**Regulatory Affairs Specialist **Responsibilities**: - Responsible for regulatory activities - Collaborates with cross-functional departments to ensure timely implementation of document change requests - Develop and establish policies and standards that convey the best practices in the company - Work closely with lab and sales team to help drive quality...
-
Regulatory Affairs Specialist
2 weeks ago
Singapore ALCOTECH PTE. LTD. Full timeAlcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia. Role Overview We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...
-
Regional Regulatory Affairs Specialist
2 weeks ago
Singapore HUNT TALENT PARTNERS PTE. LTD. Full time $57,600 - $72,000 per yearMedical Devices MNC headquartered in JapanNew regional role covering AsiaBase salary up to $4,800/month + AWS + VBWe are working with a Medical Devices MNC with its HQ based in Japan. They have a strong vision to provide high quality standards and innovations. With a staff strength of over 20,000 employees in APAC and are well known for multiple therapeutic...