Regulatory Affair Executive

Key Responsibilities:

• Ensure products meet all local and international regulatory requirements
• Prepare, review, and submit regulatory documents including dossiers, technical files, and product registrations
• Communicate with regulatory agencies to obtain approvals and resolve queries
• Manage regulatory aspects of product changes (formulation, packaging, labeling)
• Assist in regulatory audits and inspections by providing necessary documentation and support
• Obtain and maintain licenses and approvals for products across various markets
• Stay updated on changes in regulatory guidelines and ensure company compliance
• Collaborate with R&D, QA, and Production teams to ensure regulatory compliance throughout the product lifecycle
• Maintain and update technical files and EU Declaration of Conformity
• Provide regulatory guidance to other departments for product launches and modifications
• Ensure post-market surveillance and vigilance requirements are met
• Must Knowledge of ISO 13482

Qualifications & Skills:

• M.Pharm in R.A.
• Min. 2 of experience in Regulatory Affairs (preferably in Medical Equipment)
• Strong understanding of regulatory frameworks (e.g., FDA, EU MDR, CDSCO)
• Excellent documentation and communication skills
• Ability to work cross-functionally and manage multiple projects