DRA (Drag Regulatory Affair) Assistant Manager

Bal Pharma

10 - 12 years

7 - 9 Lacs

gurugram

Posted:2 months 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 regulatory affairs row market latam

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilities (5 days working)

Manage regulatory dossiers for solid oral products, including CTD and ACTD preparation and submission to global markets.
Handle team responsibilities related to dossier compilation, review, and approval.
Ensure compliance with GMP regulations and provide guidance on regulatory affairs matters within the organization.
Collaborate with cross-functional teams to ensure timely completion of tasks and meet project deadlines.
Provide expertise in ASEAN, LATAM markets Team Handling, and Dossier Preparation.

Desired Candidate Profile

M.Pharma degree from a recognized university with 10-12 years of experience in drug regulatory affairs.
Strong understanding of CTD ACTD format for regulatory submissions (USFDA & EU).
Experience working on Solid Orals formulations is essential.
Excellent communication skills for effective collaboration with internal stakeholders and external partners.

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