Regulatory Affairs (Team Lead) -Kurla

Flamingo Pharmaceuticals; Navi Mumbai; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Flamingo Pharmaceuticals, based in Navi Mumbai, seeks a Lead Regulatory Affairs with 6–10 years of experience in regulatory submissions for tablets and capsules. The role covers USFDA, MHRA, EU/UK markets and CTD/eCTD dossier management, with cross-functional team coordination to ensure timely approvals.

The candidate will oversee regulatory strategy, dossier preparation, and post-approval changes, contributing to successful market registrations and ongoing compliance in a dynamic pharma

Qualifications

• 6–10 years’ Regulatory Affairs experience in tablets and capsules.
• Experience with USFDA, MHRA, EU/UK markets and CTD/eCTD dossiers.

Responsibilities

• Lead regulatory submissions for tablets and capsules across USFDA, MHRA, EU and UK.
• Manage CTD/eCTD dossiers and product registrations.
• Coordinate with teams to ensure timely approvals.

Skills

Regulatory affairs

USFDA

CTD/eCTD

Education

B.Pharm / M.Pharm

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.