Assistant Manager Regulatory affairs

Job Description

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. Should be well versed in Product Stewardship Expert, REACH, TSCA, GHS Regulations &CLP. Please share your resume on kailas.avhad@vvfltd.com Show more Show less