Drug Regulatory Affairs

2 weeks ago

New Delhi, India Curiza Life Sciences Full time

**Job Role: International Regulatory Affairs**

Responsible for compilation & submission of Dossier of a generic drug.

Hand on experience in Filing dossiers to regulated, emerging and ROW markets.

Experienced in CTD/ACTD and Regional Module.

Experience in Filing in EU, ASEAN, MIDDLE EAST AND LATAM regions.

To obtain approvals for relevant product marketing, Registration Certificates and export permission.
- Key Responsibilities:_

1) The Responsible for task involving evaluating dossiers/queries and compilation of critical dossiers and queries, as and when required. This includes search/retrieval/editing of data logically for preparation of dossier/query.

2) Will be responsible for maintaining high moral/discipline and secrecy of the

Regulatory Affairs Department with effective correspondence / liaison with manufacturing plants for timely procuring the required data for dossier preparation.

3) **Experience with Injectable is a must.**

1) Minimum 3-7 years of experience in Pharmaceutical Regulatory Affairs

2) Worked with Pharmaceutical Formulation Regulatory department

3) Hands on experience to manage formulation regulatory

4) Willing to travel both domestic and international (may be for long durations like a month or so)

**Job Types**: Full-time, Regular / Permanent

**Salary**: ₹300,000.00 - ₹800,000.00 per year

Schedule:

- Fixed shift

Supplemental pay types:

- Performance bonus

**Experience**:

- total: 7 years (preferred)

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