Senior Executive Regulatory Affairs

3 weeks ago

Jhajjar, India Lifecell Full time

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

Email Id -

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