Regulatory Affairs Executive Thane

Regulatory Affairs Executive Thane

31 Jul
|
Oviani Pharmachem
|
Thane

31 Jul

Oviani Pharmachem

Thane

We are looking for young and enthusiastic minds, who will be responsible for the following roles
1. Preparation and compilation of CTD and ACTD dossiers for Vietnam, Myanmar and ROW market
Review of Process Validation, Analytical Method Validation, Product Development Records, BMR, BPR, Stability data, Certificate of Analysis etc. required for dossiers
Co-ordinate with departments such as Manufacturing, Product Development, QA/QC, R&D;, Legal, Purchase etc. to ensure availability of documents and samples for submission.
To check & review Art-works, Labels, and Pack-inserts
Response of queries and other requirements as required by respective regulatory authorities in a stipulated time frame

Pay: ₹180,000.00 - ₹264,000.00 per year

Schedule:
Day shift
Morning shift

Ability to commute/relocate:
Hiranandani Estate, Thane, Maharashtra: Reliably commute or planning to relocate before starting work (required)

Education:
Bachelor's (preferred)

Experience:
Dossier Preparation: 1 year (required)

Language:
Hindi, English (preferred)

Work Location: In person

📌 Regulatory Affairs Executive Thane
🏢 Oviani Pharmachem
📍 Thane

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