Parvati B Hanamsagar
Regulatory Affairs
Bengaluru,Karnataka
Summary
Diligent Regulatory Affairs Managers with14 years of supporting compliance management experience. Works well with consulting cross-functional teams on minimizing regulatory risk. Goes above and beyond to manage priorities and problem-solve with quick turn-around expectation.
Overview
14
14
years of professional experience
9
9
years of post-secondary education
2
2
Certifications
3
3
Languages
Work History
Manager – WW RDSA and Regulatory Affairs
HERBALIFE NUTRITION INDIA
10.2015 - Current
- Good knowledge in FSSAI & DCA Regulations and handling Registration & Import licensing of General Food, Nutritional Food, Ayurveda & Cosmetics products
- Coordinating for all licensing & Regulatory activities
- Preliminary Ingredients scientific evaluation and assist is product development
- Ayurvedic research for Ayurvedic ingredients
- Responsible to ensure company products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance
- Effectively interact and communicate with regional counterparts, manufacturers, and other departments (including Project Management, QA, and R&D/Scientific Affairs) with regard to all aspects of product compliance and the product lifecycle
- Conduct review of preliminary and concept formulas and supporting documentation to determine overall acceptability and appropriate product classification, for use in corporate initiatives and product launches, including the assessment of ingredients, nutritional claims, and other formula specifications
- Develop, request, and review supporting technical and non-technical data and documentation from manufacturers, technical libraries, and various departmental sources
- Develop country specific labels by extracting information from formula and specification sheets; assess label acceptability and identify discrepancies based on country labelling regulations
- Responsible for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Regulations
- This includes the review, evaluation, and compilation of files and reports for submissions
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary
- Monitor regulatory affairs activities to ensure that they are aligned with corporate sustainability or green initiatives.
- Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery
- Launched new products and services with thorough market research, leading to increased revenue growth
- Defined clear targets and objectives and communicated to other team members
- Successfully managed budgets and allocated resources to maximize productivity and profitability
Executive – Domestic Regulatory Affairs
M/S. THE HIMALAYA DRUG COMPANY
01.2014 - 10.2015
- Liaising with AYUSH (Drugs and Cosmetics), FSSAI (Food Safety Standard Authority of India), and regulatory bodies for all licenses related activities for new and existing products
- Assisted in all kinds of regulatory requirement for registration and international queries for Pharma products, Herbal Cosmetics, Food products, Oral Care etc., with close association and with registration cell.
Executive – QFS (Regulatory Affairs)
M/S. CADBURY INDIA LTD (MONDELĒZ INTERNATIONAL)
10.2011 - 01.2014
- Liaise with AYUSH (Drugs and Cosmetics), FSSAI (Food Safety Standard Authority of India), and Legal Metrology, regulatory bodies for all licenses related activities for the factory and for new and existing products
- Track and maintain regulatory (AYUSH, PFA/FSSAI, Legal Metrology) compliance requirements of the products
- Assist all the quality and food safety and external audits of the plants.
- Led product teams for regulatory product compliance on Candies and Bubble gum
Research Executive – Regulatory Affairs
M/S. NATURAL REMEDIES PVT LTD
03.2010 - 10.2011
- Experience in Domestic and International Regulatory Affairs and IPR
- Liaise with AYUSH (Drugs and Cosmetics), PFA (Prevention of Food Adulteration), Legal Metrology and Agriculture Dept
- (Insecticide Act and Rules), regulatory bodies for all licenses related activities for the factory and for new and existing products
- Artwork and Label management.
Education
Some College (No Degree) - Auyurveda
Sri DGM Ayurvedic Medical College Gadag
Gadag (Karnataka) 01.2003 - 01.2008
Some College (No Degree) - PUC II
State Board
Dandeli 01.2001 - 12.2002
10th -
State Board
01.1998 - 04.2000
Skills
Regulatory Affairs
Food & Drug regulations
Quality systems
Product development
Attention to detail
Organizational skills
Written communication
Verbal communication
Critical thinking
Strategy planning
Decision making
Integrity
Planning
Collaboration
Business Development
Time Management
Process Improvement
Personal Information
Date of Birth: 08/26/85
Accomplishments
- Soley represented India Regulatory Affairs and helped in Launch of multiple new products under FSSAI nutraceutical Regulations.
- The New FSSAI Nutraceutical Regulations were applied to all products on the market, assisting in the timely relaunch of items that complied with the regulations and receiving recognition for the same.
- Collaborated closely with all cross-functional teams to produce the vritilife Ayurvedic brand launch, for which I was recognized with an award.
- Contributed in launch of Brain Health, Immune Health & Triphala Tablets under new Ayurveda Brand.
- Was invited to travel from India to the US for orientation
- Resolved several product issues which were picked by FSSAI officers
Certification
[Area of certification], [Company Name] - [Timeframe]
Timeline
Manager – WW RDSA and Regulatory Affairs
HERBALIFE NUTRITION INDIA
10.2015 - Current
Executive – Domestic Regulatory Affairs
M/S. THE HIMALAYA DRUG COMPANY
01.2014 - 10.2015
Executive – QFS (Regulatory Affairs)
M/S. CADBURY INDIA LTD (MONDELĒZ INTERNATIONAL)
10.2011 - 01.2014
HACCP Certification - By DNV
11-2010
Research Executive – Regulatory Affairs
M/S. NATURAL REMEDIES PVT LTD
03.2010 - 10.2011
Some College (No Degree) - Auyurveda
Sri DGM Ayurvedic Medical College Gadag
01.2003 - 01.2008
Some College (No Degree) - PUC II
State Board
01.2001 - 12.2002
10th -
State Board
01.1998 - 04.2000
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