
Regulatory Affairs Associate Director
3 weeks ago
1 week ago Be among the first 25 applicants
Responsibilities- Manage the entire process of getting new drugs approved in the US and EU, from initial research all the way through post-market changes.
- Develop and evaluate submission documents covering key administrative, summary, and clinical data, maintaining strict adherence to ICH and local regulations.
- Communicate directly with regulatory agencies like the FDA, EMA, and MHRA to handle questions, inspections, and label discussions.
- Help develop and carry out registration plans for new markets in regions like Southeast Asia (ASEAN) and the Middle East/North Africa (MENA).
- Work closely with different teams (like manufacturing and clinical research) to make sure all submitted information is scientifically sound.
- Advanced degree (Master's or PhD) in Pharmacy, Biology, or a related discipline.
- Over 5 years of international regulatory affairs experience, having led at least two successful FDA or EMA drug approvals from initiation to completion.
- Skilled in electronic submission platforms (e.g. Veeva RIM)
- Specialized in registering vaccines and biologics, covering areas such as influenza, COVID-19, and HPV.
- Previous experience as a reviewer or regulator at FDA, EMA, or MHRA is advantageous.
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Regulatory Affairs Associate Director
2 weeks ago
Singapore Ethos BeathChapman Full time**Job Details**: **Location** Singapore **Salary** Competitive Salary **Job Type** Permanent **Ref** BH-178593 **Contact** Piers Atkinson- **Posted** about 1 hour ago - A new entrant to Asia, this Biopharma is looking for a Regulatory Affairs Associate Director. - You will be in charge of all things regulatory in APAC where currently they don’t...
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Regulatory Affairs Associate Director
1 week ago
Singapore TRITON AI PTE LTD Full timeRegulatory Affairs Associate Director / Director 1 week ago Be among the first 25 applicants Responsibilities Manage the entire process of getting new drugs approved in the US and EU, from initial research all the way through post-market changes. Develop and evaluate submission documents covering key administrative, summary, and clinical data, maintaining...
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Regulatory Affairs Director
1 week ago
Singapore Novo Nordisk Full timeRegulatory Affairs Director **Category**:Reg Affairs & Safety Pharmacovigilance **Location**:Singapore, Singapore, SG **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...
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Regulatory Affairs Associate
2 weeks ago
Singapore INTEGRITY PARTNERS PTE. LTD. Full time**Regulatory Affairs Associate with global Medical Device MNC**Opportunity to work on local and regional submissions Partnering with a global Medical Device MNC with an established branding, our client is seeking a **Regulatory Affairs & Quality Assurance Executive (6-Months Contract)**. Reporting to the RA/QA Director, we are looking for someone with good...
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Singapore Allergan Full timeCompany Description AbbVie\'s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people\'s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products...
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Regulatory Affairs Manager
6 days ago
Singapore DSM-Firmenich Full timeCOMPANY DESCRIPTION As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create...
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Singapore Allergan Full timeCompany Description AbbVie\'s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people\'s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and...
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Regulatory Affairs
6 days ago
Singapore TERUMO ASIA HOLDINGS PTE. LTD. Full timeThe 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 hands-on execution priorities with regional...
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Director, Regulatory Affairs
2 weeks ago
Singapore Kimberly-Clark Full time**Your Job**: The Director, Regulatory Affairs - APAC K-C Professional (KCP) & Consumer leads the regional regulatory affairs team for APAC (Asia-Pacific, Australia & China), and is responsible for establishing, implementing and maintaining required regulatory compliance for the business. The APAC Regulatory Affairs team provides strategic regulatory...
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Regulatory Affairs
2 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 ...