Manager - Regulatory Affairs

Overview

Location: Chennai/ New Delhi

Position Objective :

• To execute on the global regulatory programs in accordance with current global regulations and ensuring that Kemin India meets all regulatory obligations in terms of product label requirements and registration of products in the operating countries.
• The incumbent will coordinate the collection of information and documentation and compile into submissions, license renewals, periodic updates and registration with regulatory agencies and partner worldwide
• The incumbent will be responsible for the review of labelling, leaflets, SPC, product development and manufacturing documents for compliance with regulatory requirements

Responsibilities

• Ensure that a company's veterinary biological/animal vaccine products comply with the regulations of the regions where they want to distribute them.
• Develop and write clear arguments and explanations for new product licenses and license renewals.
• Monitor and set timelines for license variations and renewal approvals.
• Prepare documents for registration of products in India (Form 12/44/40/8/9), Bangladesh, Sri Lanka and Nepal.
• Ensure all products labels are in alignment with the regulations of the country.
• Safe keep confidential documents.
• Provide strategic advice to senior management throughout the development of a new product.
• Review company practices and provide advice on changes to systems.
• Assist in arranging internal and external meetings.
• Organize travel arrangements.
• Preparation and submission of bills to finance department.
• Ensure that updated SDS and product description sheets are available.

Qualifications

• Master's Degree in Chemistry / Biochemistry / Veterinary / Microbiology with 5 to 7 years’ experience
• Knowledge in regulatory aspects related to food and feed industry is preferrable.

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