Manager - Regulatory Affairs (RoW)

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. A combination of medical devices and pharma will be a plus.

Desired candidate profile:

1) Minimum 4-8 years of experience in Pharmaceutical Regulatory Affairs

2) Worked with Pharmaceutical Formulation Regulatory department

3) Hands on experience to manage formulation regulatory

Job Type: Full-time

Pay: ₹30,000.00 - ₹70,000.00 per month

Work Location: In person