Regulatory Affairs Executive

Key Responsibilities

• Regulatory Compliance (India):
• Ensure product compliance as per Drugs & Cosmetics Act, AYUSH guidelines, and FSSAI standards.
• Handle product licensing, renewals, and NOC applications for Ayurvedic and nutraceutical products.
• 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.

Desired Candidate Profile

• 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