Role & responsibilities
Publish Electronic Submission of registration dossier, variations, annual reports and responses to questions in eCTD format via the Electronic Submissions Gateway (ESG), Common European Submission Portal (CESP) or equivalent submission portal utilizing in-house publishing software.
Prepare documents for submission by scanning, rendering, bookmarking, and hyperlinking.
Perform quality checks for document integrity and compliance to regulatory standards.
Troubleshoot document issues and provide guidance to company employees on best practices and regulatory requirements.
Prepare and maintain electronic templates that will be used company-wide for preparation of submission documents.
Convert paper submissions to electronic publishing, as required.
Submit Structured Product Labeling/Drug Listings to FDA via the Electronic Submissions Gateway (ESG), as required.




Submit Establishment Registrations to FDA via the Electronic Submissions Gateway (ESG), as required.
Prepare and submit safety reports to FDA and Health Canada via the ESG, as required.
Manages compilation and submission of Periodic Adverse Event Reports for USFDA, as required.

Update himself/herself with the relevant current USFDA, EMEA and ICH guidances and requirements

Preferred candidate profile

PCC is seeking a highly motivated and detail-oriented PCC-Regulatory Publisher to join our Regulatory Affairs team in India. This role is responsible for the compilation, publishing, and submission of high-quality regulatory documents to health authorities, ensuring compliance with global regulatory requirements and internal standards.

📌 Regulatory Publisher Role Mumbai
🏢 Piramal Pharma
📍 Mumbai