Regulatory Affairs Pharmacist
1 week ago
Job Description: Ensuring timely regulatory submissions for new products, indications, renewals and variations to maintain current registration of all products. Liaising with and ensuring compliance with HSA as well as Principal's requirements pertaining to post-market activities. Review and approval of advertising and promotional materials. Ensuring compliance with HSA requirements for Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Distribution Practice for Medical Devices in Singapore (GDPMDS). Participate in the maintenance and improvement to the company's Quality Management System, including Management Review. Supports RA/QA Manager for Internal and External Audits. Ensure compliance with Principal's Quality Agreement. Serve as the Deputy Pharmacovigilance (PV) contact between the company, HSA, and principals, to support the maintenance of the company's Pharmacovigilance system in accordance with local and principals' requirements. Conduct training for Standard Operating Procedures (SOP) and PV compliance. Provision of adequate and relevant medical information. Responsible for timely and accurate tender submissions, maintain oversight and management of tender portfolio. Skills and Qualifications: Degree in Pharmacy Registered Pharmacist with the Singapore Pharmacy Council Strong attention to detail, well‐organised with problem‐solving skills. Good written / verbal communication skills Team player MS Office Preferably minimum 1-2 years of experience in regulatory submissions, quality system & assurance will be advantageous. Knowledge of GxP such as Good Manufacturing Practice (e.g. PIC/S) / Good Distribution Practice / Good Pharmacovigilance Practice, SS620 Good Distribution Practice for Medical Devices / ISO13485#J-18808-Ljbffr
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Regional Regulatory Affairs Manager
7 days ago
Singapore Talentreq Partners Pte Ltd Full timeAPAC regulatory affairs - Pharmaceutical industry - Singapore registered pharmacist Reporting to the Head of Regulatory Affairs, you will be responsible for assimilating knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required legislation. You will provide strategic...
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Specialist, Regulatory Affairs
7 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...
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Job Title
7 days ago
Singapore CADENCE GROUP PTE. LTD. Full timeJob Responsibilities: - Work closely with the supplier/manufacturer and regulatory authorities/bodies regarding product submissions and compliance. - Prepare product technical dossiers for regulatory submission for both new products and existing product’s variation. - Liaise with relevant parties to resolve product registration and regulatory issues. -...
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Regulatory Affairs Executive
2 weeks ago
Singapore LABGISTICS ASIA PTE. LTD. Full time**Responsibilities**: **Regulatory and Compliance Duties** - Main liaison with regulatory and government bodies regarding Regulatory works including but not limited to product registrations (including LABG and its customers’ products etc), regulatory related enquiries from internal and external stakeholders and updating of regulatory requirements etc. -...
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Pharmacist, Regulatory
2 weeks ago
Singapore Miraco Nutripharm Pte Ltd Full timeDescription Pharmacist, Regulatory & Business Operations Join to apply for the Pharmacist, Regulatory & Business Operations role at Miraco Nutripharm . At Miraco Nutripharm, we are dedicated to advancing health and improving lives. Our goal is to relieve 1 billion people worldwide of pain and discomfort. If you know of anyone who has been worried about or...
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Regulatory Affairs Manager
7 days ago
Singapore Artixio Consulting Pvt Ltd Full timeThis is a full-time hybrid role as a Regulatory Affairs Manager at Artixio. The Regulatory Affairs Manager will be responsible for ensuring regulatory compliance, managing regulatory requirements, overseeing regulatory submissions, and maintaining quality systems. The role is based in Singapore but allows for some remote work. **Qualifications** - Minimum...
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Regulatory Affairs
2 weeks ago
Singapore Search staffing services pte ltd Full time $120,000 - $150,000 per yearOur client is an exciting American medical devices startup in the field of pregnancy assisted birthing instruments. The company is rapidly expanding its operations here in Singapore and is looking for the position of Regulatory Affairs & QMS Manager.Regulatory Affairs & QMS Manager.Reporting to the Chief QARA Officer (Based in Singapore), you will be...
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Regulatory Affairs Specialist
5 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...
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Regulatory Affairs Specialist
1 week 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...
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Regulatory Affairs Specialist
7 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...