DGM - Regulatory Affairs

Sentiss Pharma Pvt. Ltd.; Gurugram District; On-site; INR 2,800,000 - 4,200,000; Full time

Job summary

Sentiss Pharma Pvt. Ltd. is seeking an experienced Regulatory Affairs leader to define and drive global regulatory strategies for generics, complex generics, and NDAs across development and lifecycle stages.

You will own end-to-end regulatory submissions across US, Australia, Canada, EU, and other stringent markets, ensuring alignment of CMC, clinical, non-clinical, and labeling components with cross-functional teams.

Qualifications

• M.Pharm degree required.
• 12–15 years regulatory affairs experience in pharmaceutical industry, with exposure to generics, complex generics, and NDAs.
• Global market exposure US, Australia & Canada, plus Europe, Brazil GCC, China, Japan, Russia/CIS.

Responsibilities

• Define and execute global regulatory strategies for generics, complex generics, and NDAs across development and lifecycle stages.
• 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 labeling 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 coordinate with R&D, Clinical, Quality, Manufacturing, IP, Supply Chain, and Commercial.

Skills

Regulatory strategy

Leadership

Stakeholder management

Communication

Education

M.Pharm

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)