Regulatory Affairs Executive

Join 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...

Overview 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...

Regulatory Affairs & QMS Manager Reporting to the Chief QARA Officer (Based in Singapore), you will be responsible for: Regulatory Affairs & Compliance Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility. Interpret and apply global medical device regulations and...

Salary 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,...

Manager/Sr Manager, Regulatory Affairs CMC Job Description At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue...

Coverage: 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...

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...

Responsibilities Support development and execution of regulatory strategies aligned with Haw Par’s strategic priorities. Prepare regulatory dossiers for new registrations, variations and renewal submissions to authorities in compliance with current regulatory requirements. Collaborate with cross-functional teams including Marketing, Quality, R&D and...

Product registration: including preparation of registration dossier, design of performance evaluation study and manage execution and communication with CRO (clinical research organization) Be the subject matter expert on medical devices laws and regulations for product registration in company's regions of interest Interface the communication with regulatory...

Key Responsibilities: Regulatory Submissions & Approvals Prepare, compile, and submit product registration dossiers to HSA and other relevant regulatory authorities. Maintain up-to-date knowledge of Singapore’s Health Sciences Authority (HSA) guidelines, ASEAN Common Technical Dossier (ACTD), and other regional requirements. Ensure timely approvals for new...