Regulatory Affairs Executive
6 hours ago
Responsible for collating and compiling the dossiers for filing in different International
markets like Africa, Asia, Latam, CIS & EU markets as per Relevant Regulatory
guidelines of Pharmaceutical dosage forms like Tablets/Capsules/Dry syrup/Liquid
syrup/Sterile Injectables (powder & liquid) /Ophthalmic/Semi solid preparations.
Co-ordinating with various cross functional team members for collecting the
documents required for compilation of dossiers.
Responsible for addressing queries received for submitted dossiers.
Accountable for reviewing and approving all master documents and review of
executed documents (like Specifications, Test Methods, Batch Production Records,
Stability Protocols and Reports, etc.) prior to submission.
Responsible for Preparation & Compilation of Module-4 & Module-5 documents for
generic products.
Responsible for executing assigned activities for eCTD life-cycle document
management within the document management system.
Labelling text development for packaging materials and artwork review.
Preparation of Product Information Form.
Preparation of PSUR packs.
**Job Types**: Full-time, Permanent
**Salary**: ₹20,000.00 - ₹30,000.00 per month
Schedule:
- Day shift
**Experience**:
- REGULATORY AFFAIRS: 2 years (required)
Work Location: In person
**Speak with the employer**
+91 9140434355
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