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Regulatory Affairs Executive

3 weeks ago

Indiranagar Bengaluru Karnataka, India Kerala Ayurveda Limited Full time

**Key Responsibilities**
- **Regulatory Compliance (India)**:

- Ensure product compliance as per **Drugs & Cosmetics Act**, **AYUSH guidelines**, and **FSSAI** standards.
- Prepare and review technical documents, dossiers, and regulatory submissions.
- **Labeling and Claims Review**:

- Review and approve all labels, artwork, and marketing claims for compliance with **Indian regulations**, **Magic Remedies Act**, and international standards.
- Work closely with Marketing, R&D, and Legal teams to ensure all packaging and promotional materials are regulatory compliant.
- **International Regulatory (US/EU)**:

- Support documentation as per **USFDA dietary supplement** regulations (21 CFR), including structure/function claim substantiation and DSHEA compliance.
- Assist in preparing dossiers and responding to queries related to **EFSA (EU)** compliance, including Novel Food dossiers if needed.
- Coordinate with cross-functional teams for Prop 65 warnings, allergen declarations, and supplement fact panels.
- **Documentation and Audit Readiness**:

- Maintain regulatory records and product master files.
- Prepare for and support internal audits and regulatory inspections.
- Stay updated with changes in national and international regulations and advise the team accordingly.
- **Education**: B.Pharm/M.Pharm Regulatory Affairs
- **Experience**: Minimum 5 years in a Regulatory Affairs role handling both domestic and international markets
- **Technical Skills**:

- Strong understanding of D&C Act, AYUSH regulations, FSSAI compliance
- Familiarity with USFDA dietary supplement guidelines (including NDI, GRAS) and EFSA regulatory pathways
- Working knowledge of QMS, GMP, and documentation standards

**Job Types**: Full-time, Permanent

Pay: ₹700,000.00 - ₹1,000,000.00 per year

**Benefits**:

- Cell phone reimbursement
- Health insurance
- Leave encashment
- Life insurance
- Provident Fund

Schedule:

- Day shift

Work Location: In person

Application Deadline: 11/07/2025