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 adhering to them.
• Providing regulatory support for "New product development", "Original design manufacturing" businesses & VVF's own brand- Softsens.
• Monitoring and analyzing regulatory trends, guidelines, and industry best practices to proactively identify new and evolving regulations that may impact the organization. This involves conducting regulatory research, participating in industry forums, and staying updated with relevant publications or conferences.
• Managing and completing tasks assigned in Komrisk Application.
• Thorough understanding and interpretation of different Health Authority regulations.
• Collaborating with cross-functional teams within the organization, including R&D, quality assurance, manufacturing, and marketing departments. This involves providing regulatory guidance, reviewing technical documentation, and ensuring that products meet regulatory requirements throughout the product lifecycle.
• Developing and implementing regulatory strategies aligned with the organization's goals and objectives. This involves assessing regulatory impact, identifying potential risks or challenges, and providing recommendations to ensure compliance and expedite product approvals.
• Collaborating with the quality assurance team to ensure that quality systems and processes are aligned with regulatory requirements. This may include participating in internal audits, supporting corrective and preventive actions, and addressing non-compliance issues.
• Providing support in corporate Quality functions.

Key Skills

• Thorough understanding of Drugs & Cosmetics Act 1940 & it's rules 1945 & Cosmetics Rules 2020
• Thorough understanding & knowledge of relevant BIS standards, ICH Guidelines & ISO Certifications
• Experience in applying regulatory applications in SUGAM portal & CDSCO portal