Sentiss Pharma Pvt. Ltd.
Website:
sentisspharma.com
Job details:
JOB DESCRIPTION
Responsible for defining and executing global regulatory strategies for generics, complex generics, and NDAs across development and lifecycle stages, ensuring timely approvals, regulatory compliance, and business alignment across key global markets.
Key Responsibilities:
- Lead regulatory strategy including Para II/IV, first‑to‑file, exclusivity, and accelerated approval pathways.
- Own end‑to‑end ANDA/NDA/DMF submissions, lifecycle filings, and eCTD publishing for US, AU, Canada, EU, Eurasian, and other stringent markets.
- Ensure alignment of CMC, clinical, non‑clinical, and labelling components across submissions.
- Manage FDA and global agency interactions, including CCs, CRLs, IRs, DRLs, inspections, and audits.
- Drive regulatory intelligence and translate evolving requirements into business‑focused actions.
- Lead and mentor the Regulatory Affairs team and ensure strong cross‑functional coordination with R&D, Clinical, Quality, Manufacturing, IP, Supply Chain, and Commercial.
Core Skills:
- ANDA Para II/IV, complex generics, NDA submissions, eCTD publishing
- Strong regulatory strategy, leadership, and stakeholder management
- Excellent communication with ability to simplify regulatory complexity
Qualification & Experience:
Education: M.Pharm
Experience:12–15 years of relevant Regulatory Affairs experience in the pharmaceutical industry, with exposure to generics, complex generics, and NDAs.
Market Exposure - US, Australia & Canada (plus exposure to Europe , Brazil GCC, China, Japan, Russia / CIS countries).
Dosage Forms: Ophthalmic, Liquid Inhalation (plus exposure to Otics/Injectables)
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