DRA (Drug Regulatory Affair) Assistant Manager

Bal Pharma

9 - 10 years

7 - 9 Lacs

gurugram

Posted:1 day ago| Platform:

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Skills Required

drug regulatory affairs team handling actd ctd formulation solid orals dossier preparation asean dossier compilation gmp compliance usfda row market latam

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilities (5 days working)

Dossier (CTD, ACTD & Country Specific Format) review for Latam, ASEAN, CIS & African countries.
Collaborate with various departments within the organization, such as Plant (QA, QC, Production, Packing & Purchase) and R&D, to gather the necessary inputs for regulatory submissions.
Compilation and timely submission of Dossiers to the respective regulatory authorities in the assigned countries. Planning, monitoring, review, strategy & delegation of the below mentioned activities for Countries:
New Product Registration, Re-Registration, Retention, Tender.
Handling of queries from various regulatory authorities/consultants.
Post Approval Changes
GMP (Countries) application
Responsible for conducting gap analyses, updating master data, reviewing change controls,

process validations, and artworks.

To review administrative, artworks, non-clinical documents.
To maintain the regulatory database & status.

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