Manager - DRA (ROW)

Curiza Life Sciences; New Delhi; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Curiza Life Sciences in India seeks a regulatory affairs professional to compile and submit dossiers for generic drugs, and to manage filings across regulated, emerging and ROW markets.

You will handle CTD/ACTD and Regional Module work, coordinate with manufacturing plants, and ensure data is retrieved and edited for dossier preparation; injectable experience is required, and medical devices + pharma exposure is a plus.

Qualifications

• Experience preparing and submitting regulatory dossiers for generic drugs.
• Hands-on filing in EU, ASEAN, Middle East, CIS and LATAM regions.
• CTD/ACTD and Regional Module knowledge.
• Experience with injectable products is required.
• Medical devices exposure plus pharma is a plus.

Responsibilities

• Compile and submit dossiers to regulators for generic drugs.
• Coordinate data retrieval/editing for dossier preparation.
• Liaise with manufacturing plants to obtain required data.
• Ensure compliance and maintain confidentiality of the Regulatory Affairs department.

Skills

Dossier filing

CTD/ACTD experience

Regulatory submissions

Regional filings

Liaison with manufacturing

Job description

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, CIS AND LATAM regions.
To obtain approvals for relevant product marketing, Registration Certificates and export permission.
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.
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.
Experience with Injectable is a must.

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