Zenith Drugs Looking for Regulatory Executive

Established in 2000 in Indore, Zenith Drugs is a premier pharmaceutical manufacturing and trading company specializing in branded, generic, and OTC products. As the first pharmaceutical company set to be listed on the NSE, Zenith Drugs offers world-class generics and formulations, including ORS Powder, Liquid Orals, Ointments, Liquid Externals, and Capsules, all developed with a focus on safety, efficacy, and affordability.

Looking for candidates ready to expand globally. Seeking individuals with skills and ambition to thrive on an international scale. Focused on those who can adapt and grow in a global.

Post : Regulatory Executive

Job Description
• Responsible and Accountable for Preparation/Compilation of registration, re-registration dossier and variation application as per registration guidelines for various countries.
• A Preparation of Finished Product Dossier as per ACTD, CTD & Country specific guideline with different dosage form Tablet, Capsule, Injection (liquid, Dry and PFS), Eye and Eardrops .Suspension, Dry Syrup, Sachet formulation etc
• Conduct through reviews of artwork, pertaining to new registration, Re-registration and variation as per registration guidelines for various countries
• Directly communication with Marketing Team for Dossier, Query and registration status.
• Arrange and dispatch of product sample along with supporting documents of various countries Review product permission, COPP & FSC and coordination with drug department
• Review the drug master file (DMF) and co-ordinate with API Vendor to resolve Queries.
• Oversee the preparation and maintenance of all regulatory documents and Records (registration tracker, Aging Analysis, Archival Maintain.)
• Responsible to timely submission GMP application for various countries.
• Tender working (African country like Ethiopia and Kenya)
• Every Month Meeting with Management for Update status.
• Dossier Planning every month and discuss with regulatory team.

Candidate Profile
• Minimum qualification : Bachelor's in Pharmacy or Life science (mandatory).
• Minimum of 4-6 years' experience in the pharmaceutical Industry in a regulatory position.
• Preferred working for South east Asia, West Africa, Latam and CIS countries.
• Good Command over English (Oral & Written).
• Computer literate with programs such as word, excel, and PowerPoint.

Corporate Office : 210 B, Scheme No. 134, Star Square, Nipania Indore, Indore - 452010
Factory : 72/5, & 72/3,72/4,74/1/1,75/1/1 Muradpura, (Orangpura) Dhar Road Near Kalaria, Indore (MP) Pin : 453001 India