Company Introduction
iCretegy Solutions is a pharmaceutical focused organization supporting regulatory and compliance driven documentation services for domestic and international markets.
Core Responsibilities
- Compile regulatory submission files using dossier checklists, product data sheets, and approved document indexes.
- Prepare module wise documentation sets by assembling study reports, stability summaries, and formulation records.
- Review labeling drafts against regulatory guidelines using approved reference manuals and check formats.
- Maintain submission trackers through spreadsheet logs and regulatory status registers.
- Archive regulatory documents in controlled folders using document numbering systems and version records.
- Prepare query response files by collating clarification documents and reference attachments.
Skills and Technical Exposure
- Common Technical Document structure and submission checklists.
- Regulatory submission trackers maintained in spreadsheet software.
- Dossier compilation guidelines for regulated markets.
- Labeling formats and product information leaflets.
- Document control logs and version history records.
Experience Context
- Work is performed in a regulatory documentation office supporting pharmaceutical product filings.
- Documentation volumes include multiple products with varied strengths and dosage forms.
- Absence of this role results in delayed submissions, incomplete dossiers, and regulatory query escalations.
How to Apply
inquiry@icretegy.com
