Regulatory Affairs Executive
1 week ago
Key Responsibilities
- Prepare, review, and submit regulatory applications to regulatory authorities.
- Monitor and track submission progress, approvals, renewals, and variations.
- Maintain up-to-date regulatory documentation, records, and filing.
- Review product labels, artworks, and related materials for regulatory compliance.
- Conduct routine literature searches for safety updates and maintain post-market safety documentation.
- Monitor regulatory changes and ensure continued compliance with local regulations.
Requirements
- Bachelor's Degree in Science, Pharmacy, Biotechnology, or a related field.
- 2–3 years of regulatory affairs experience preferred (strongly motivated fresh graduates may also be considered).
- Ability to understand and interpret regulatory guidelines and technical documents with strong analytical skills.
- Excellent attention to detail and proficiency in document filing and record management.
- Strong written and verbal communication skills.
- Self-motivated, responsible, and able to manage multiple tasks and meet deadlines independently.
- Knowledge of regulatory guidelines for pharmaceuticals, medical devices, cosmetics, and/or food products (preferred).
- Familiarity with pharmacovigilance and post-market surveillance processes is a plus.
-
Regulatory Affairs Specialist
23 hours ago
Subang Jaya, Malaysia Sysmex (Malaysia) Sdn Bhd Full time**Roles & Responsibilities**: - Submit new product registration of medical devices and reagents and ensure submissions are done in a timely manner. - Engaging with government bodies such as the MDA (Medical Device Authority) to ensure compliance with local guidelines. - Regular reporting on registration status to management. - Keeping up to date with...
-
Regulatory Affairs Pharmaceutical
1 week ago
Petaling Jaya, Malaysia BioCare Pharmaceutical Sdn Bhd Full timeBiocare Group is a leading pharmaceutical company committed to improving global health through the development and commercialization of innovative healthcare products. With a strong focus on research and development, Biocare Group aims to provide safe and effective treatments for patients worldwide. **Summary** We are seeking an experienced and highly...
-
Regulatory Affairs Executive
7 days ago
Petaling Jaya, Malaysia Elanco Full timeEducation : EQUIVALENTEXPERIENCE **At Elanco (NYSE: ELAN) - it all starts with animals!** **As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to...
-
Senior Executive, Regulatory Affairs
3 days ago
Petaling Jaya, Selangor, Malaysia DKSH Full timeJob SummarySupervise the execution of company quality assurance (QA), safety, health & environmental (SHE) and registration (REG) policies and standards, guarantee the regulatory compliance to local and international laws and regulations*General Responsibilities*Support superior in managing day-to-day operating expenditures against operating budgets to...
-
Manager Regulatory Affairs
1 week ago
Petaling Jaya, Malaysia DKSH Full timeLocation: Petaling Jaya, MY, MY - Global Business Unit: HEC - Job Function: Regulatory Services - Requisition Number: 173560 - Description: **Job Summary**: Manage the local implementation of the company quality assurance (QA), safety, health & environmental (SHE) and registration (REG) policies and standards, guarantee the regulatory compliance to local and...
-
Regulatory Affairs Executive
1 week ago
Petaling Jaya, Malaysia TLV Logistics Sdn Bhd Full time**Job Scope**: - Assist in timely product registration submission and also Halal certification. This includes compiling, reviewing & filing of dossiers for the registration/notification submission & also Halal certification. - Assist SAH Regulatory Affairs Team maintain Product Information File (PIF), technical information as well as other Regulatory...
-
Regulatory Affairs Specialist
7 days ago
Petaling Jaya, Selangor, Malaysia Nexus Wise Sdn Bhd Full timeMinimum Qualification : Graduated in Bachelor's Degree in Life Sciences such as Food Science, Nutrition etc.Years of Experience : Minimum 1-2 years in Regulatory Affairs / Quality Assurance / any position with MAL submission experienceLocation : Petaling Jaya, MalaysiaCompany : Nexus Wise Sdn BhdWorking Hour : Monday to Friday (9.00am -...
-
Manager, Regulatory Affairs, APAC
1 week ago
Petaling Jaya, Selangor, Malaysia Johnson & Johnson Innovative Medicine Full timeAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...
-
Regulatory Affairs Executive
3 days ago
Subang Jaya, Malaysia Delfi Marketing Sdn Bhd Full time**Responsibilities** - To ensure regulatory compliance of the Company’s products and licenses - To prepare and review regulatory documentations and submissions related to pharmaceutical products, traditional medicines, health supplements, medical devices, cosmetics, veterinary products and/or any other regulated products to regulatory bodies - To keep...
-
Regulatory Pharmacists
1 week ago
Subang Jaya, Selangor, Malaysia PHARMASOLUTION SDN BHD Full timeKey ResponsibilitiesRegulatory Strategy & CompliancePrepare and submit product registration dossiers (CTD/ACTD format) for pharmaceuticals and medical devices.Manage lifecycle activities including renewals, variations, site transfers, and labeling updates.Monitor regulatory changes (NPRA, MDA, ASEAN, ICH) and communicate updates to internal...