Assistant Manager - Regulatory Affairs

Key Responsibilities

• Ensuring compliance of printed packaging materials & marketing collaterals with applicable regulations to ensure completeness, accuracy and compliance with regulatory guidelines.
• Overseeing the preparation and submission of regulatory applications, dossiers, and variation filing to regulatory authorities for product registrations, manufacturing licences, GMP liceneces, Free Sale Certificates, product permissions, import/export licenses, and post-market surveillance. This includes ensuring accuracy and completeness, and meeting submission deadlines.
• Responding to queries raised by State Licencing Authorities.
• Responding to queries raised by internal functions as well as external customers.
• Ensuring compliance with relevant laws, regulations, and guidelines pertaining to the industry, such as health authority regulations. This involves staying updated on regulatory changes and guiding the organization in adh...