Job Responsibilities :

- Co-ordination with all the parties for ongoing and new product submissions
- To prepare & review registration dossiers in ACTD, CTD for Africa, Latam, South East Asia, Middle East & PIC/S countries.
- To Study the guideline for product registration thoroughly, ensure product registration of dossiers as per the guidelines, compilations of data and arranging specific data required for registration.
- Timely submission of Technical Documents, Tender Documents, and LOA to procurement agencies.
- Prepare the various Applications like Mfg. Lic, Product permission, free sale certificate, COPP, Domestic Tender Documents, Chemist Approval to Food and Drug Administration in Time.
- Liaoning with state FDA, CDSCO, DCGI- for manufacturing licenses, export licenses
- Agreements To draft, review & comment on the Distribution, Promotion, Agency, MOU Plan




- Technical Support to Head International Business/Director for the business development. Technical support to the International Marketing Department.
- To update the working status of Regulatory department & to keep control on Regulatory work.
- Customer Complaint: Domestic and International - Final answers to send to respective departments for sending to custome

Desired Candidate Profile

- 5-9 years of experience in Regulatory Affairs with a focus on pharmaceutical industry.

- Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma) from an accredited institution.

- Robust understanding of ECTD, CTD, dossier compilation, regulatory guidelines, and regulatory submissions.

📌 Assistant Regulatory Affairs Manager (Maharashtra)
🏢 Ciron Drugs & Pharmaceuticals
📍 Maharashtra