Regulatory Affairs-Kurla

Flamingo Pharmaceuticals; Navi Mumbai; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Flamingo Pharmaceuticals in Navi Mumbai seeks a seasoned Regulatory Affairs professional to lead submissions for tablets and capsules across USFDA, MHRA, EU and UK markets. You will manage CTD/eCTD dossiers, product registrations, and post-approval changes while coordinating with cross-functional teams to secure timely approvals.

The ideal candidate has 6–10 years of Regulatory Affairs experience in tablets and capsules, with a proven track record in handling US FDA processes and regulatory

Qualifications

• 6–10 years of Regulatory Affairs experience in tablets and capsules.
• Experience handling US FDA submissions across multiple markets (USFDA, MHRA, EU, UK).

Responsibilities

• Lead regulatory submissions for tablets and capsules (USFDA, MHRA, EU, UK).
• Manage CTD/eCTD dossiers, product registrations and post-approval changes.
• Coordinate regulatory queries and ensure timely approvals.

Skills

Regulatory submissions

CTD/eCTD

USFDA submissions

Compliance

Team coordination

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 US FDA =