Executive/ ive

2 days ago

Hyderabad, India Sarvotham Care Full time

We are seeking a highly skilled and detail-oriented Regulatory Affairs Executive / Senior Executive to join our dynamic team. The ideal candidate will have hands-on experience in applying for and managing regulatory licenses required for the import of raw materials and manufacturing of pharmaceutical, nutraceutical, and Ayurveda products. The role demands expertise in navigating Indian regulatory frameworks, including CDSCO, FSSAI, AYUSH, and obtaining Dual NOCs, Import Licenses, and product registrations.

Key Responsibilities:

  • Import Licensing & Raw Material Compliance

  • Apply for and manage raw material import licenses through CDSCO or other relevant bodies.

  • Coordinate with suppliers, freight forwarders, and customs for clearance of imported goods.

  • Ensure compliance with DGFT, customs, and drug control authorities regarding import activities.

  • Dual NOC Applications

  • Prepare and submit documentation for obtaining Dual NOC (Food & Drug Authority) approvals.

  • Liaise with both FSSAI and CDSCO for smooth and timely approvals.

  • CDSCO Regulatory Work

  • Apply for and manage drug manufacturing licenses, test licenses, and formulation registrations under CDSCO.

  • Track changes in regulations and ensure product compliance at all stages.

  • Coordinate with internal QA/QC and R&D teams to ensure regulatory documentation aligns with product specs.

  • FSSAI Licensing

  • Apply for and maintain FSSAI Central and State licenses for nutraceutical and food products.

  • Handle product approvals, label compliance, and liaise with FSSAI officials as required.

  • AYUSH Licensing

  • Coordinate and apply for manufacturing and product licenses under the Ministry of AYUSH.

  • Ensure regulatory compliance specific to Ayurveda, Siddha, and Unani product categories.

  • Documentation & Compliance

  • Maintain updated regulatory files, product dossiers, and tracking logs.

  • Assist in audits and inspections conducted by regulatory authorities.
  • Regularly monitor and communicate changes in relevant regulatory guidelines and policies.

Key Requirements:

  • Bachelors or Masters degree in Pharmacy, Life Sciences, or Regulatory Affairs.
  • 3–7 years of hands-on experience in licensing and regulatory documentation in a CDMO or pharma/nutraceutical setup.
  • Strong knowledge of CDSCO, FSSAI, and AYUSH regulations.
  • Experience in applying for import licenses, dual NOCs, and handling regulatory correspondence.
  • Familiarity with SUGAM, FSSAI FoSCoS, Ayush e-Aushadhi portals.
  • Excellent communication and coordination skills.
  • Ability to work independently and handle multiple licensing processes simultaneously.

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