EXECUTIVE / SR. EXECUTIVE - REGULATORY AFFAIRS

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