Regulatory Affairs Head -Kurla

Flamingo Pharmaceuticals; Navi Mumbai; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Flamingo Pharmaceuticals seeks an experienced Regulatory Affairs Lead to manage USFDA, MHRA, EU and UK submissions for tablets and capsules from our Navi Mumbai site, ensuring compliance and timely approvals.

You will oversee CTD/eCTD dossiers, product registrations, variations and post-approval changes, handle regulatory queries, coordinate the regulatory team, and mentor junior staff to meet ambitious timelines.

Qualifications

• B.Pharm/M.Pharm with 6–10 years’ Regulatory Affairs experience in tablets and capsules.
• Experience handling USFDA, MHRA, EU/UK markets, CTD/eCTD dossiers, product registrations, variations, and team management.

Responsibilities

• Lead regulatory submissions for tablets and capsules across multiple markets.
• Manage CTD/eCTD dossiers, product registrations, variations, and handle regulatory queries, compliance, and team coordination to ensure timely approvals.

Skills

Regulatory affairs

Education

B.Pharm/M.Pharm

Tools

CTD/eCTD management

Job description

Lead regulatory submissions for tablets and capsules in USFDA, MHRA, EU and UK markets. Manage CTD/eCTD dossiers, product registrations, pre- and post-approval changes, regulatory queries, compliance, and team coordination to ensure timely approvals.

Required Candidate profile

B.Pharm/M.Pharm with 6–10 years’ Regulatory Affairs experience in tablets and capsules, handling USFDA, MHRA, EU/UK markets, CTD/eCTD dossiers, product registration, variations, and team management.