Regulatory Affairs Apprentice

Program Duration: 1-Year Apprentice Program
Post-Apprenticeship Role: RA Associate

Role Outline:
The Regulatory Affairs (RA) Apprentice will support the maintenance of regulatory compliance mandates, including FSSAI, Legal Metrology, and other applicable standards. The role involves statement preparation for new product endorsements, license renewals/modifications, and submission of annual and quarterly returns.

This program provides hands-on training and exposure to regulatory frameworks and compliance procedures, equipping you with the skills to transition to an RA Associate role after one year.

Key Deliverables:

1. Operational Support FSSAI Compliance

• Review and ensure compliance of formulations as per FSSAI guidelines, including pack size checks and client license reviews.
• Identify gaps in compliance and recommend necessary modifications to align with regulatory mandates.
• Validate and review LCs (Label Claims) and artworks for new product prototypes and existing products. Coordinate with stakeholders to implement required changes based on FSSAI, ICMR RDA mandates.
• Validate shade cards and coordinate with QC and packaging vendors for necessary adjustments.
• Collaborate with departments to update BOM (Bill of Materials) based on recommended formula or artwork changes to maintain compliance.
• Address client queries related to product or artwork compliance mandates.

2. Operational Support AYUSH Compliance

• Arrange and compile MFR (Master Formula Report) data from R&D, finished goods testing reports, and PMT (Product Management Team) comments for health claims to prepare Product Approval Copies for submission to AYUSH Licensing Authority.
• Review and finalize artwork compliance as per the Drugs & Cosmetics Act (D&C Act).
• File Schedule TA with the National Medicinal Plant Board and AYUSH Authority within the required timelines.

What You Will Learn:

• Comprehensive understanding of FSSAI, AYUSH, and Legal Metrology compliance requirements.
• Skills in reviewing and validating formulations, labels, and artworks against regulatory standards.
• Hands-on experience in managing regulatory filings, license modifications, and client queries.
• Coordination with cross-functional teams such as R&D, QC, and packaging for compliance-related tasks.
• Knowledge of regulatory documentation and filing procedures for AYUSH and FSSAI.

Eligibility Criteria:

• Qualification: B.Pharm/ MSc. in Food / B.Tech in Food
• Passion for understanding and applying regulatory standards.
• Strong communication and coordination skills.

Program Benefits:

• 1-year intensive training program with structured learning opportunities.
• Placement as an RA Associate upon successful completion.
• Exposure to real-world regulatory challenges and solutions.

If you are eager to build a career in Regulatory Affairs and learn through hands-on experience, this is the perfect opportunity for you!