Officer - Regulatory Affairs

6 days ago

Thane, India ALTAIR LIFESCIENCE Full time

**Job description**
- Reviewing, Compilation, Preparation of Registration Dossiers CTD, ACTD & country specific Dossiers as per country's guidelines.
- Handling registration queries, Developing samples for registration.
- Review of technical documents like, specifications, Certificate of Analysis, Method of Analysis, Test Methods, Testing Reports, Stability Protocols, Stability Data & Product Development Reports.
- Artwork preparing in Corel draw software, development: Checking of Artworks, leaflets and labels, requirements for labelling, storage & approval for the same. (Preparation of Patient Information Leaflet)
- Co-ordinate with other departments of Production, QA & QC on requirements, issues related to deficiencies and on any technical problem.
- Drafting of Label claim compositions.
- Studying scientific & Legal documents.
- Application for legal documents such as Manufacturing License, Product Permissions, FSCs, COPPs etc. for registration purpose and as per requirement.
- Arranging the samples (reference samples) for Registration Purpose.
- To maintain and update all documents and dossier records. To update registration status.
- Handling purchase and supply and maintaining data.

Pay: ₹10,000.00 - ₹20,000.00 per month

Schedule:

- Day shift

Ability to commute/relocate:

- Ambarnath, Thane - 421501, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 3 years (required)

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