Role Purpose

To assist Associate Vice President - Quality to drive Quality & Regulatory compliance agenda in all geographies Must have Well conversant with FDA requirements of FMCG, Food and Oleo-Specialty Chemical licensing requirements and on expedited pathways. Well versed with UK REACH (DUIN & NRES), China NMPA, Korea REACH, Turkey REACH, Vietnam REACH, Eurasia REACH, Australia REACH and or other country specific chemical Regulations Key Responsibilities :

Regulatory Intelligence

Review and submission of Product License application for the new 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.

Planning and Strategising

Coordination in finalizing the Annual Quality Audit schedule of all the supplier, audit observation, closure action CAPA plan and compliance score as per the defined measurable, Proactive sharing of the weak area and strong area to address the Gaps proactively.

Policy and Process Design, Implementation and Review

Quality Compliance - Governance, Business Support: Responsible for ensuring the effective Coordination and communication support, Scheduled Monthly Regulatory Meet & Compliance issues with Sales & Marketing, Vendor Management System (Audit & compliance), Training and Development.

Coordination, Interface, Imparting Training to Internal and External entities

Vendor Management System : Availability & adherence of Vendor audit schedule and its adherence (audit report /CAPA plan if any) its closure, Recent vendor qualification followed by SQA

Management of performance, capability and morale

📌 Assistant Manager Regulatory Affairs (Navi Mumbai)
🏢 VVF Group
📍 Navi Mumbai