Executive - Drug Regulatory Affairs - India Market

Alkem Laboratories

Posted: 4 months ago
Openings: 10
Applicants: 0

Job Description

Role & responsibilities

1. Coordination with Stakeholders for collating documents for preparation of dossier, review of dossier and application submission to CDSCO office. (e.g. Clinical trial/BA-BE application, Marketing Authorization Application of ND/SND, FDC drugs, Import registration of New drug product/drug substance, Cosmetics, registration of biologicals)

2. Response to the queries raised from respective regulatory authority (India)

3. Compilation of applications to DDA Nepal and renewal of registration.

4. Review, Updating and approval of Artworks & Pack inserts as per rules laid by respective regulatory authority (India)

5. Preparation & Submission of PSURs to PVPI and PV cell of CDSCO for the new drugs as per CDSCO timelines.

6. Updating Stakeholders with all notification issued by respective regulatory authorities in timely manner.

7. Preparation & Submission of Application for imported Drug Substance/ Drug Product & Medical Device to CDSCO office.

8. Submission and follow ups with IPC/FDA Labs for imported and new drugs samples for Test & Analysis

9. Follow ups at CDSCO office for application submitted and coordination for deliberation of proposals in SEC meeting

10. Participation for new policy drafting at the CDSCO & IPC working committee

11. To Provide Strategy & Inputs for New Project initiation for local and imported product (Drugs, Cosmetic & Medical Device)