
Regulatory Affairs Associate Director
1 day ago
Regulatory 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 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 days 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
2 weeks 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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Singapore Johnson & Johnson Full timeThe Associate Director, Regulatory Affairs APAC Vision Care is responsible for all aspects of regulatory responsibilities in APAC VC. Critical to this role is to combine knowledge of scientific, regulatory, and business issues to enable all products that are developed, manufactured, or distributed to meet all the required legislations in all applicable...
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Director, Regulatory Affairs
2 weeks ago
Singapore beBeeRegulatory Full time $120,000 - $180,000Regulatory Affairs DirectorWe are seeking a seasoned Regulatory Affairs Director to lead our team in providing strategic regulatory support for clinical trials and drug development. The successful candidate will have excellent leadership skills, a strong understanding of international regulatory requirements, and experience in managing cross-functional...
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Associate Director, Regional Regulatory Affairs
2 weeks ago
Singapore Johnson & Johnson Full timeJohnson & Johnson is currently seeking an Associate Director, Regional Regulatory Affairs to join our Regional Regulatory Affairs team located in Asia Pacific. **Essential Job Duties and Responsibilities** - The Regional Regulatory Leader Asia Pacific (AP) (Associate Director) is a member of the Global Regulatory Affairs organization. The position resides...
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Singapore Eli Lilly Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
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Associate Director, Regulatory Affairs
1 week ago
Singapore Gilead Sciences Full timeFor Current Gilead Employees and Contractors: At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals. **Job...
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Director of Regulatory Affairs and Quality
4 weeks ago
Singapore Barrington James Full timeDirector of Regulatory Affairs and QualityDirector of Regulatory Affairs and QualityDirect message the job poster from Barrington JamesHead of Regulatory Affairs & Quality, Asia.I am engaged by a global medical devices company to appoint a Head of Regulatory Affairs and Quality for Asia.This senior leadership position will guide regulatory direction and...
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Singapore Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
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Regulatory Affairs Director
1 day 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...