
Regulatory Affairs Associate Director
4 days 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.
-
Director, Regulatory Affairs
3 days ago
Singapur, Singapore BeathChapman Pte Ltd Full timeOverview Be the Driving Force Behind Regulatory Excellence in APAC ! An expanding global Contract Research Organisation (CRO) is looking for a Director, Regulatory Affairs (APAC) to lead its regulatory team and drive strategy across the region. This is an exciting leadership role where you’ll shape submissions, guide regulatory strategy, and represent the...
-
Surveillance Regulatory Affairs Officer
4 days ago
Singapur, Singapore Marina Bay Sands Full timeJoin to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands 2 weeks ago Be among the first 25 applicants Join to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands Get AI-powered advice on this job and more exclusive features. LOVE WHAT YOU DO? THERE IS A PLACE FOR YOU HERE!Be part of our diverse and...
-
Singapur, Singapore Novartis Singapore Full timeExecutive Director, Public Affairs Asia Aspiring Join to apply for the Executive Director, Public Affairs Asia Aspiring role at Novartis Singapore Executive Director, Public Affairs Asia Aspiring Join to apply for the Executive Director, Public Affairs Asia Aspiring role at Novartis Singapore SummaryAbout the role:The ED, Public Affairs Asia Aspiring...
-
Director P&B Regulatory Affairs Asia Pacific
4 days ago
Singapur, Singapore dsm-firmenich Full timeDirector P&B Regulatory Affairs Asia Pacific Join us as the Director P&B Regulatory Affairs Asia Pacific at dsm-firmenich in Singapore. This role involves leading a regional team of regulatory experts to ensure compliance of our Perfumery & Beauty (P&B) portfolio, supporting business growth, and staying updated with industry regulations. You will develop...
-
Director, Regulatory
3 days ago
Singapur, Singapore Precision for Medicine Full timePrecision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...
-
Regulatory Affairs Lead
4 days ago
Singapur, Singapore Belt Road Capital Management Full timeRegulatory Affairs Lead / Policy Advisor (Based in Cambodia) Regulatory Affairs Lead / Policy Advisor (Based in Cambodia) Working as part of the Public Policy team and under the direction of the Head of Public Policy, this role contributes to the team’s mission by researching domestic and international regulatory frameworks, developing actionable reform...
-
Regulatory Affairs, Manager
4 days ago
Singapur, Singapore Biomed Global Full timeSalary Range MYR 7,000 - 7,999 City Bandar Sri Damansara Country Malaysia Job Description Identify regulatory requirements and stay up to date with the evolving regulatory landscape in each marketing territory.Serve as the company representative and committee member in local medical device industry associations (e.g., MMDA).Initiate, validate, review, plan,...
-
Singapur, Singapore Interactive Brokers Full timeDirector / Associate Director – Core Compliance Join to apply for the Director / Associate Director – Core Compliance role at Interactive Brokers Director / Associate Director – Core Compliance Join to apply for the Director / Associate Director – Core Compliance role at Interactive Brokers Company OverviewInteractive Brokers Group, Inc. (Nasdaq:...
-
Singapur, Singapore Goldman Sachs Full timeCompliance, Regulatory Country Compliance – Affairs, Analyst/Associate, Singapore Join to apply for the Compliance, Regulatory Country Compliance – Affairs, Analyst/Associate, Singapore role at Goldman Sachs Job Description At Goldman Sachs, we connect people, capital and ideas to help solve problems for our clients. We are a leading global...
-
Regional Regulatory Affairs Lead – Asia
4 days ago
Singapur, Singapore Charterhouse Pte Ltd Full timeCoverage: Asia Region Industry: Biologics / Specialty Pharmaceuticals Our client is a leading multinational company in the biologics sector, committed to improving patients’ lives through high-quality, innovative therapies. With a strong global footprint and a pipeline of specialty products, they are now seeking a Regional Regulatory Affairs Lead to join...