Position: Executive – Regulatory Affairs
Job Responsibilities:
- Issuance of Prior Notice to USFDA for sample.
- Preparation of various statements/declarations (e.g., Allergen, Non-GMO, Food Grade, WADA, Nitrosamine Risk Assessment, Heavy Metal Impurities, Elemental Impurities, Gluten-Free Statement, etc.) for customer scope products as per country requirements.
- Filling and submitting customer questionnaires with supporting documentation.
- Basic knowledge of company and product registration in international markets like Europe, Indonesia, Brazil, GCC countries, etc.
- Responding to customer queries.
- Basic knowledge of FSSAI/FDA registration and guidelines.
- Ensuring compliance with regulations in regions where products are distributed.
- Staying up-to-date with national and international legislation, guidelines, and customer practices.
- Preparing submissions for additional products and changes in establishment for state and central regulatory authorities.
- Collaborating with R&D, Quality Assurance, and Marketing teams to provide regulatory guidance during product development.
- Monitoring changes in regulations and industry trends, providing insights and recommendations to align the company’s regulatory strategies with market demands.
- Basic knowledge of food certifications like BRCGS, FSSC 22000, ISO 22000, HACCP, Kosher, HALAL, EIA, etc.
- Preparing qualitative and manufacturing process equivalence reports.
- Basic knowledge of government tender document preparation.
- Preparing documents for custom clearance.
Candidate Profile:
- Qualification: B.Sc., M.Sc., B.Pharm, M.Pharm, B.Tech, M.Tech, or any related field.
- Experience: Graduate with 2 years of experience.
- Location: Poicha (Rania), Vadodara
If you meet the qualifications and are interested in joining a company committed to excellence and innovation in the nutritional solutions industry, consider applying for this exciting opportunity at Sudeep Nutrition Pvt. Ltd.