Role & responsibilities

* Prepare, compile, review, and submit regulatory dossiers in CTD, ACTD, and country-specific formats.

* Prepare Modules 1 to 5 of CTD dossiers using technical documents received from manufacturing partners.

* Compile dossiers for product registration in:

* Latin American countries

* African countries

* CIS countries

* Middle East

* South-East Asia

* Other ROW markets

* Review Product Dossiers, SmPC, PIL, Labeling, Artwork, COA, Specifications, Stability Data, BE/Bioequivalence documents, and GMP-related documentation.

* Coordinate with manufacturing partners for regulatory documents and technical deficiencies.

* Handle deficiency letters, regulatory queries, and follow-up with health authorities until product approval.

* Maintain regulatory databases, submission trackers, and registration status reports.





* Ensure compliance with country-specific regulatory guidelines and documentation requirements.

* Coordinate with internal sales, export, quality assurance, production, and manufacturing teams for timely dossier submissions.

* Support product renewals, variations, amendments, and post-approval regulatory activities.

* Monitor regulatory updates and implement changes in submission requirements.

Preferred candidate profile :

* Proven experience in international dossier preparation and submissions.

* Experience in CTD, ACTD, and country-specific dossier compilation.

* Experience in handling regulatory queries and deficiency responses from overseas health authorities.

📌 Drug Regulatory Affairs (DRA) Executive / Senior Executive / Manager (Delhi)
🏢 Aneni Remedies
📍 Delhi