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ishr

ishr

EXECUTIVE / SR. EXECUTIVE - REGULATORY AFFAIRS

Company

ishr

Role

EXECUTIVE / SR. EXECUTIVE - REGULATORY AFFAIRS

Location

Ahmedabad, GJ, India

Job type

Full-time

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Salary

Not disclosed by employer

Job description

EXECUTIVE / SR. EXECUTIVE - REGULATORY AFFAIRS

No of Position : Two

Designation : Executive / Sr. Executive - Regulatory Affairs

Experience : B.Pharm/M.Pharm with minimum experience of 3 to 5 years

Company : Pharmaceutical Company

Salary : Depend on candidates experience & Industry Standard

Job Profile

  • Dossier preparation as per the ACTD & CTD (Module I, II, III, IV and V) guideline.
  • Technical documents like Raw Material and finished products specification, manufacturing process,

Product development report, stability reports, process validations preparation & review.

  • Analytical method validation review as per the ICH guideline.
  • Drug Master File review
  • Technical query response to the various regulatory authorities.

Dosage Oral solid, Liquid, Injectable, Ophthalmic, Topical

Market ROW, Latam, African Countries

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