Executive/ Sr.Executive - Regulatory Affairs

Regulatory Affairs Executive / Senior Executive

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.