CKIM PHARMA LLP hiring for Regulatory Affairs Executive @Ahmedabad
About the job
Regulatory Affairs Executive
Experience: 1-3 Years of Experience in preparing and submission of dossiers as per country requirement (Semi Regulated/ROW Countries)
Job Location: S.G.Road, Ahmedabad, Gujarat.
Vacancy : Multiple
Candidates preferred from Gujarat.
Qualification: Must Be B.PHARM/M.PHARM
Responsibilities:
- Preparing, reviewing and submitting product dossiers as per CTD (Common Technical Documents), ACTD, PQ, ROW countries as per guidelines.
- Preparing, reviewing and submitting renewal documents/renewal dossiers/ variations/responding to queries raised by Ministry of Health, International agencies as well as the various customers.
- Involved in co-ordination with Plant, R&D and QA-QC Department for preparation and receiving & reviewing of technical Documents such as DMF, Stability data, etc. and also arranging for the samples required for submission along with the product dossiers.
- Artwork rechecking. (Taking care of EU documentation)
Skills:
– Should have a strong command over written & verbal communication in English.
– Good knowledge of ICH, WHO, and regulated market
Interested candidates please share your resumes on [email protected]
