Associate Regulatory & Compliance

Drugs and Cosmetics Act, 1940

Reports to:

Responsibilities:-

Regulatory Compliance

• Ensure all cosmetic and personal care products comply with the

  Drugs & Cosmetics Act

  and

  Rules

  , including Schedule S, Q, and related labelling requirements.
• Prepare and review product dossiers for submission to

  FDA

  and other authorities.
• Track updates to Indian and international cosmetic regulations and communicate relevant changes to stakeholders.
• Verify product formulations, ingredient lists, and claims to ensure they meet regulatory standards.
• Liaise with external consultants and government departments for product approvals, notifications, and renewals.

Licensing & Documentation

• Apply for and maintain

  Cosmetic Manufacturing, Import, and Marketing Licenses

  (Form 32/33).
• Maintain accurate documentation of regulatory submissions, license renewals, and correspondence with authorities.
• Support in FDA site inspections and assist in responding to audit queries or compliance observations.
• Coordinate with Quality and Production teams to ensure adherence to

  GMP guidelines

  for cosmetics.

Labelling & Claims Compliance

• Review and approve product labels and artworks for compliance with labeling regulations under the

  Drugs & Cosmetics Rules

  ,

  Legal Metrology Act

  , and other applicable laws.
• Validate product claims (e.g., dermatologically tested, paraben-free, etc.) to ensure they are substantiated and within regulatory boundaries.

Stakeholder Collaboration

• Work closely with

  R&D

  ,

  Marketing

  , and

  Quality Assurance

  teams to support compliant product development and launches.
• Act as the regulatory point of contact for any product-related or labelling queries.

Training & Awareness

• Conduct periodic internal sessions on cosmetic regulatory updates and compliance requirements.
• Promote awareness of product safety, labelling standards, and regulatory obligations across departments.

Qualifications:

• Bachelors/Master’s degree

  in Pharmacy, Cosmetic Technology, Chemistry, or related field.

• 1–3 years

  of experience in

  Regulatory Affairs (Cosmetics / Personal Care)

  .
• Strong understanding of

  Drugs & Cosmetics Act and Rules

  ,

  BIS Standards

  , and

  FDA procedures

  .
• Experience in label and artwork compliance review.
• Detail-oriented with strong documentation and communication skills.

Key Performance Indicators (KPIs):

• Timely submission and renewal of cosmetic licenses and approvals.
• Zero major non-compliances during audits and inspections.
• Accuracy of product labelling and claim validations.
• Regulatory readiness and adherence to changing guidelines.