Assistant Manager- Regulatory Affairs

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 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.
• 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 legislation and guidelines.
• Compile, prepare, review and submit regulatory submission to authorities.
• Develop new regulatory policies, processes and SOPs and train key personnel on them.
• Collect, collate, and evaluate scientific data to support regulatory submissions.
• Provide regulatory guidance and support to internal teams, including product development, manufacturing, and quality control.
• Assess and communicate impact of relevant regional regulations / standards in domestic and International market

Preferred candidate profile

Well conversant with FDA requirement 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 and or other country specific chemical regulations.