Deadline
Open Deadline
Location
Nagpur, Maharashtra.
Salary
Compensation details will be finalized during the interview process with the selected candidate.
Details of the Organization
ZIM LABORATORIES LIMITED is a research driven pharmaceutical company who develop, manufacture and supply differentiated generic products in the oral solid dosage forms, both as pre-formulation intermediates as well as finished formulation for certain key therapeutic segments.
Details of the Job/Internship
ZIM LABORATORIES LIMITED is looking for candidates for the role of Regulatory affairs officer.
Role and Responsibilities
- Preparation, review and planning of submission of CTD/ACTD/ECTD for export market.
- Floating of official email for technical documents and queries reply.
- Prepare/monitoring site registration documents for export market.
- Registration/Re-registration/post approval changes application for export market.
- Resolve the technical query related to product registration/Re-registration/post approval changes.
- Follow-up and coordination with internal stake holder ( QA, QC, R&D, Technical services
- Department, production, packing, account, purchase & business development).
- Review of technical documents, Process validation, Stability data, Analytical method validation,
- Product development report, finished product specification, Qualitative Quantitative formula
- Standard testing procedure, batch manufacturing record, batch packing record, certificate of
- Analysis, container and closure system and open part Drug master file.
- To intimate & review of BE study from Approved BE center.
- Follow-up with manufacturing site for register sample, working standard & impurity requirement for lab analysis.
- To prepare monthly regulatory status report and status of new registration/Re-registration/post approval changes.
- Coordination with stakeholder for collecting documents for preparation of dossier, review of
- dossier and submission to respective regulatory authority.
- Review of artwork and pack insert as per rules laid by respective regulatory authority.
- Preparation and submission of Product safety update report.
- Coordinate the renewal of FDA license (GMP, COPP, manufacturing license, wholesale).
Eligibility
Experience: 3 years to 6 years
Salary/Stipend
Compensation details will be finalized during the interview process with the selected candidate.
Type of Opportunity
Fulltime
Country
India
State
Maharashtra
City
Nagpur
Address
Nagpur, Maharashtra.
Application and Registration Details
Once you apply, the next steps in the application process will be sent to you via e-mail.
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Contact: [email protected]
Would you like to apply immediately?
Once you apply, the next steps in the application process will be sent to you via e-mail.
