Regulatory Affairs Executive

1 years

1 - 5 Lacs

Posted:1 day ago| Platform: GlassDoor logo

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Work Mode

On-site

Job Type

Full Time

Job Description

· Preparation and Compilation of ACTD, CTD, country specific dossiers for product to be submitted in ROW Market.

· Preparation of query response for the dossiers

· Review of the technical documents like BMR, Specification, Method of analysis, COA for Raw material, packing material and finished product

· Preparation and review of the artwork technical details

· Maintain the technical documents for the products

· Maintain the FDA license documentation like Product permission, CoPP, FSC and related expenses

· Maintain the tracking for the documents sent for the notary, legalization

· Apart from the above listed responsibility we can assigned the other work based on the potential of the candidate

Job Types: Full-time, Permanent

Pay: ₹12,085.70 - ₹48,591.37 per month

Benefits:

  • Health insurance
  • Leave encashment
  • Paid sick time
  • Provident Fund

Schedule:

  • Day shift

Education:

  • Master's (Preferred)

Experience:

  • Dossier Compilation : 1 year (Required)

Location:

  • Ahmedabad, Gujarat (Required)

Work Location: In person

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