Officer - Regulatory Affairs

2 months ago


Dwarka Delhi Delhi, India Harasha Pharma Pvt ltd Full time

Ø Preparation and reviewing of administrative documents.

Ø Preparation and Review of Dossier in CTD, ACTD and ECTD Format.

Ø Preparing the SPC/ Leaflet/ SMPC as per country guidelines.

Ø Preparation of Dossier for CIS, Africa countries, ASEAN, EU, LATAM, ROW and Gulf Countries,.

Ø Review and Making of Stability Data, Analytical Method Validation, Process Development record.

Ø Review of DMF (Close part)

Ø Review of Labels and Literature as per the country guideline

Ø Preparation of COA, MSDS, Packing Specification, Finished Product specification.

Dossier in CTD, ACTD and ECTD Format: 2-5 years (preferred)
REGULATORY AFFAIRS- FINISHED FORMULATION
- Preparation and reviewing of administrative documents.
- Preparation and review of Dossier in CTD, ACTD and ECTD Format.
- Preparing the SPC/ SMPC/ Leaflet as per country guidelines.
- Preparation of Dossier For CIS, Africa countries, ASEAN, EU, LATAM, ROW and Gulf Countries.
- Review and making of stability data, Analytical Method Validation, Process Development record.
- Review of DMF (Close Part, Open Part)
- Review of Labels and literature as per the country guideline
- Preparation Of COA, MSDS, Packing Specification, Finished Product Specification
- To Oversite third party manufacturing quality, COA and Control Samples
- To Co-ordinate with Warehouse, Designer, Cross Functional team
- Having Experience in handling audit of manufacturing site
- Making of STP, Manufacturing Flow Chart
- Preferred From Pharma finished products Background
- Review of Labels and literature artwork

Schedule:

- Day shift
- Monday to Friday
- Morning shift

**Education**:

- Bachelor's (preferred)

**Experience**:

- minimum: 2 years (preferred)

Work Location: In person



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