Regulatory Affairs Executive

SUN PHARMA WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia Regulatory Affairs Executive

To ensure compliance with national and international regulatory requirements by preparing, reviewing, and submitting product registration dossiers and variations, while supporting cross-functional teams in maintaining product quality, safety, and efficacy. Key Responsibilities : Regulatory Submission & Compliance Prepare, compile, and submit product registration dossiers to regulatory authorities (e.g., NPRA and HSA) within stipulated timelines. Handle applications for new registrations, renewals, variations, and post-approval commitments. Maintain regulatory databases and tracking systems to ensure up-to-date product status. Documentation & Review Review and ensure accuracy of product labeling, artwork, packaging, and promotional materials in compliance with regulatory guidelines. Maintain and update regulatory files, records, and product dossiers. Review technical documents (e.g., CMC, stability data, clinical reports) to ensure regulatory compliance. Monitor and interpret changes in local and international regulations, guidelines, and standards. Provide regulatory guidance to internal teams (R&D, QA / QC, Production, Marketing). Act as a point of contact between the company and regulatory authorities. Coordinate with external stakeholders (regulatory consultants, partners, contract manufacturers). Support audits and inspections by health authorities. Cross-Functional Support Work closely with Quality Assurance (QA) and Quality Control (QC) to ensure compliance with GMP and GDP. Support product lifecycle management and regulatory strategy for new product development. Cross-functional communication to ensure smooth regulatory submissions and compliance. Job Requirements : Bachelor’s degree in Pharmacy or a related field (e.g., BPharm, PharmD) / Biomedical Sc. / Other health Life sciences / Science). Familiar with NPRA, HSA, ASEAN, ICH guidelines. Proficiency in managing regulatory databases and tools. Knowledge of adverse event reporting systems and safety databases. Ability to review and manage regulatory and safety documents with precision. Strong ability to liaise with regulatory authorities, internal teams, and external stakeholders. Seniority level

Associate Employment type

Full-time Job function

Business Development and Sales Pharmaceutical Manufacturing

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