Senior Executive Regulatory Affairs

Key Responsibilities:

• Preparing and submission of Sterile Finished Product application CT-10, CT-12, CT-16, CT-21,
  
  Form-30, Free sale certificate, Certificate of Pharmaceutical Product, WHO-GMP.
  
  Endorsement of Sterile product under the manufacturing licence.
• Licensing to State drug controller & for getting the licence within a time period given by
  
  management.
• Submission of IND & NDA application of biological products (Cell lines/Tissue Engineered
  
  products)
• Compilation & review of Dossier according to CTD Modules (Module -1,2,3,4 and 5).
• Review the CMC documents of new product development.
• Compilation and review of Medical device(s)- Device Master Files.
• Preparation of the dossier as per checklist of CDSCO MD Rules 2017.
• Submission of WholeSale & Retails Licence.
• Labelling and Implementation of Medical Devices, Drug product, Biological product &
  
  Cosmetics products.

Requirements:

• Education: Bachelors/Masters degree in Pharmacy, Life Sciences, or a related field.
• Experience: 3-5 years in Regulatory Affairs within the pharmaceutical, biologics, or medical
  
  device industry.
• Skills: Knowledge of CDSCO, WHO-GMP, and CTD guidelines, experience in dossier
  
  preparation & regulatory submissions, strong coordination skills, and understanding
  
  of Medical Device Rules 2017.

Important Note: "For the first 6 months, the training will be at the Head Office located in Chennai. Travel expenses and accommodation will be provided by the company."

Contact us;

Siva

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