Role & responsibilities

To assist Associate Vice President - Quality to drive Quality & Regulatory compliance agenda in all geographies.
- Review and submission of Product License application for the current product / renewal well in time as per the scheduled commercial product manufacturing plan.
- Effective dossier compilation, review and submission plan followed by regulatory queries evaluation and timely response to obtain expedited product registration; drafting company's response towards government notifications.
- Facilitate and co-ordinate plant audits conducted by regulatory/certification bodies/customer audits.
- Liaise with stakeholders - R&D;, Quality, marketing, legal in obtaining necessary product, process and plant related technical information for submission ; certifying bodies and regulatory authorities Facilitate regulatory inputs/reviews during the product development and audit preparation within the scope of quality & regulatory compliance.
- Regulatory review of supplier quality agreement, Labeling information, Claim grid, ingredients INCI names,



country specific caution etc.
- Evaluate and submit the application for post approval changes in product permission as per the variation regulation of respective country and as directed by the Global head.
- Liaise with stakeholders on changing regulatory landscape in countries like India/Latam/US/EU/Middle East/GCC/Russia-CIS/Africa regions.
- Regular updated database of site wise - product wise licenses with validity period; and regulatory compliance. Stay updated on changes in regulatory requirements and communicate these changes to relevant stakeholders. Educate staff on regulatory requirements and updates.
- Customer / regulatory queries and complaint evaluation with timely closure response ensuring regulatory compliance.
- Well conversant with FDA requirements of FMCG, Food and Oleo-Specialty Chemical licensing requirements and on expedited pathways.
- Keeping up to date with changes in regulatory leg

📌 Assistant Manager- Regulatory Affairs (Taloja)
🏢 VVF
📍 Taloja