About the role
MediCore’s regulatory team of 22 files for the US, EU, and semi-regulated markets from its Genome Valley campus, and this position works on the US generics portfolio. You will see a dossier through from compilation to approval, including authoring deficiency responses — work that many companies reserve for senior staff. The team runs on a five-day week, which is still uncommon in Hyderabad pharma.
Key responsibilities
- Compile Modules 1–3 of eCTD dossiers for ANDA submissions in publishing-ready form
- Draft responses to FDA deficiency letters in coordination with R&D and plant QA
- Review change controls and assess their regulatory impact across filed markets
- Maintain the submission tracker and alert stakeholders 30 days before commitment dates
- Prepare annual reports and amendments for approved products
- Track FDA and CDSCO guidance updates and circulate monthly impact summaries
Requirements
- 2–4 years in regulatory affairs at a formulations company filing for regulated markets
- Hands-on eCTD compilation experience with publishing tools
- Understanding of stability requirements per ICH Q1 and dissolution comparisons
- Precise written English — deficiency responses leave no room for ambiguity
- Ability to chase cross-functional inputs politely but persistently to meet dates
Nice to have
- Exposure to EU decentralised-procedure filings
- Experience with regulatory tracking software such as Veeva RIM
- Participation in a successful FDA pre-approval inspection
About the employer
MediCore Labs is a Hyderabad-based formulations company with 60+ ANDA approvals and finished-dosage plants in Telangana and Himachal Pradesh, exporting to 40 countries. Its US business contributes half of the ₹1,900 crore annual revenue.