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Home
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Acme Formulation
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Regulatory Affairs Executive

Regulatory Affairs Executive

Acme Formulation

3 - 8 years

3 - 8 Lacs

Nalagarh

Posted:4 days ago| Platform:

Apply

Skills Required

Drug Regulatory Affairs CTD Dossier Preparation Row Market Row Ectd Emerging Markets

Work Mode

Work from Office

Job Type

Full Time

Job Description

Key Responsibilities:

Dossier Compilation:

Prepare, compile, and review regulatory submissions (CTD/ACTD format) for ROW & emerging markets.
Work on Module 1 (administrative/legal), Module 2 (summaries), and Module 3 (quality) for OSD products.
Ensure dossier accuracy, completeness, and alignment with country-specific requirements.

Regulatory Compliance:

Ensure all documentation complies with
ICH
,
WHO
, and respective
country-specific guidelines
.
Maintain awareness of evolving regulatory requirements across ROW markets.

Coordination & Liaison:

Coordinate with internal teams: QA, QC, Production, Packaging, and F&D for data collation.
Liaise with external stakeholders like regulatory consultants and agents for submissions and queries.

Product Lifecycle Management:

Manage variations, renewals, query responses, and product registration maintenance.
Handle change control and post-approval regulatory activities.

Document Control:

Maintain updated regulatory records and submission trackers.
Ensure timely and organized archiving of all submitted dossiers and correspondence.

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