Assistant Manager - Regulatory Affairs (Ahmedabad)

Assistant Manager - Regulatory Affairs (Ahmedabad)

17 Sep
|
Troikaa Pharmaceuticals
|
Ahmedabad

17 Sep

Troikaa Pharmaceuticals

Ahmedabad

Role & responsibilities

- Responsible for planning and review of recent registration and re-registration dossiers for the ROW US, Europe, UK and Brazil Market.

- Evaluation of queries received from various regulatory authorities and response preparation for country submission.

- Responsible for Life cycle management and post approval activities (variation).

- Coordination with various departments and arrangement of documents and its review for dossier preparation.

- Review of documents and registration dossiers before the submissions.

- Responsible for updating and managing Regulatory related software.

- Artwork review and its management.

- Training and Monitoring on changes in regulatory guidelines and timely implement and inform to Stake holders.

- Responsible for work distribution, supervising and managing team of 2-5 members.

📌 Assistant Manager - Regulatory Affairs (Ahmedabad)
🏢 Troikaa Pharmaceuticals
📍 Ahmedabad

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