Profile summary:
Food Regulatory Affairs Professional having expertise in handling Nutraceuticals, Health Supplements, Food for Special Dietary Uses, Food for Special Medical Purposes, Prebiotics, Probiotics, Standards and Proprietary Food Product.
My key knowledge areas are Product Licensing, Marketing Claim Design, Manufacturing Regulatory Compliance, Scientific Affairs, Nutrient Profiling, Labeling Compliance (Domestic and Export), Product feasibility Design, Ingredients/Additives Compliance, Dossier preparation, Literature review, RDA Compliance.
Provide strategic direction and operational management of the Regulatory affairs and compliance staff in order to successfully navigate the Regulatory process.
Served as Regulatory Affairs Specialist, executing and supporting to domestic product registrations.
Preparation & Review of artwork compliance as per Food Safety and Standards (Packaging and Labeling) Regulations, 2011 and Legal metrology for domestic products and Preparation & Review of artwork for export products for Asia, Europe, Africa, North America and Australia as well. Evaluate labeling changes and promotional materials for regulatory impact and to ensure compliance with applicable regulations.
Well versed with Food Safety and Standards Act, 2006 and Regulations 2011, Legal Metrology (Package Commodities) Rules, 2011 made there under till date. Experience in implementing Regulatory Compliances associated with new issuance, amendments & notifications from Regulatory Bodies.
Handling Adjudication process associated with FSSAI pertaining to Non-compliances, Notices, Technical Response to Notices received from State/ Central Food Safety Officers & Enforcement Division.
Also having experience in the Cosmetic import registration in the India..
Work Experience :
Regulatory Affairs Mgr
2014-03-04 - 2019-10-30
Preparation, review, submission of registration documents for product approval of food/food supplements, Health supplements, Nutraceuticals, Additives and Ingredients.
Preparation, review, submission of registration documents for scientific panel of food/food supplements, Health supplements, Additives and Ingredients.
Prepare word text of labels, Review and comments on labeling of food/food supplements, Health supplements, Nutraceuticals, Additives and Ingredients as per Food Safety Standard Act 2006 and Rules 2011(Packaging and Labeling Regulation, 2011).
Experience in providing product claims, health claims and nutrient claims of food, food supplements/ health supplements products so as to get competitive advantage.
Experience in regulatory assessment of formulation development in Food/ Food supplements, Health Supplements and Nutraceuticals.
Handling technical queries/deficiencies from regulatory authority (from Food Safety Standards Authority of India).
Experience in generating the standard specification of the product/ingredient to comply with specific monograph
Well coordinated with the various department like R&D, QA, QC for regulatory submission
Having International exposure in relation to the labeling requirement for the country specific (i.e. Australia, GCC Countries, Bangladesh, Sri-Lanka, Singapore, South Africa etc.).
Import registration of cosmetic products in India.
Composition Review of Cosmetic Products, dossier preparation, to review the label claim and assist in getting the local manufacturing license.
Regulatory Affairs Mgr
2019-10-31 - Presently working
Artwork compliance as per Food Safety and Standards (Packaging and Labeling) Regulations, 2011 and Legal Metrology for domestic products and Preparation & Review of artwork for Export products for Asia, Europe, Africa, North America and Australia as well. Evaluate labeling changes and promotional materials for regulatory impact and to ensure compliance with applicable regulations.
Composition Review and to make compliance as per the Food Safety and Standards Regulations, 2011 and 2016 and Legal Metrology for the In-House and Third Party product as well.
To assist R&D in making the specification for raw materials and finished products.
To make compliance of all the Food and Nutraceutical Products to FSSAI.
To make application of the food product to the Food Authority (Central and State) and filling for getting the FSSAI license.
Preparation, Review, Submission of registration documents for the product approval of the nutrients and additives as per the Non-specified Food/ Ingredient Approval.
Preparation, Review, Submission of Vegan registration documents for the Vegan product approval of the products.
Reviews the different marketed products provided by marketing team and accordingly make suggestion to them.
Coordinate with the R&D, Marketing, Packaging, Production team for the data generation and collect the data from them to make application on time bound manner.
Coordinate with the plant team and supply chain team for feasibility of the artworks and packaging material on time.
Coordinate with the external lab for product testing.
Review the market complaint about product and response to the Authority.
To assist R& D and Marketing Team for making claim on the artwork.
Regular Check the FSSAI updates and share with every concerned department.
Registration of Food Products in the Legal Metrology as per the Legal Metrology (Package Commodities) Rules, 2011.
Sole Responsibility of maintenance of regulatory Affairs Product files to support compliance with Regulatory requirement.
