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 (India)
🏢 Aneni Remedies
📍 India