Regulatory Affairs Associate

Indore
Full-Time
Mid-Level: 4 to 6 years
Posted on Mar 05 2025

About the Job

Skills

Regulatory submissions
FDA regulations
Document management systems
EMA guidelines
Labeling compliance
eCTD submissions
Clinical trial applications
Risk management planning

Regulatory Affairs Executive

 


Job Description:

 

·       Compliance: Nutraceuticals have specific guidelines that include health claims, ingredient safety, labeling, and product testing.

·       International Regulations: Knowledge of European Food Safety Authority (EFSA), FADA, or WHO (World Health Organization) guidelines should also be known.

·       Product Registration and Approval Process & Dossier Preparation

·       Health Claims and Labeling.

·       Review of Quality Assurance and Control & Quality Testing and Documentations.

·       Risk Management and Safety, Adverse Event Reporting and Product Recalls.

·       Knowledge of Industry Trends and Market Insights.

 

Skills Required:

 

Regulatory Knowledge-

o  Laws and Regulations: You must have knowledge of the rules and regulations of FSSAI (Food Safety and Standards Authority of India), FDA (Food and Drug Administration), and CDSCO (Central Drugs Standard Control Organization). These organizations make regulations for nutraceuticals.

 

Experience Required: 3-5yrs.

Job Location: Indore


Interested candidates must send their resume to hr@thehimalayanorganics.in or contact us at 7880098984

About the company

Himalayan Organics is a Neutraceutical brand. It caters health and beauty solutions.

Industry

Health, Wellness & Fitnes...

Company Size

11-50 Employees

Headquarter

Indore

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