Regulatory Manager

Flamingo Pharmaceuticals; Navi Mumbai, Mumbai; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Flamingo Pharmaceuticals in Navi Mumbai is seeking a seasoned UK MHRA Regulatory Affairs professional to lead the regulatory strategy for new products. You will drive global submissions and coordinate with cross-functional teams to ensure timelines and quality.

Responsibilities include preparing, reviewing and submitting Marketing Authorization Applications to the UK MHRA, compiling CTD/eCTD dossiers, and maintaining alignment with MHRA guidelines. The ideal candidate holds B.Pharm/M.Pharm/M.Sc.

Qualifications

• 8–15 years in UK MHRA Regulatory Affairs.
• B.Pharm/M.Pharm/M.Sc. required.
• Expertise in MAA, CTD/eCTD, RFI responses, lifecycle management and cross-functional coordination.

Responsibilities

• Prepare, review & submit Marketing Authorization Applications (MAA) to UK MHRA.
• Compile, review & submit CTD/eCTD dossiers for new product registrations.
• Ensure compliance with current UK MHRA guidelines & regulatory requirements.

Skills

MAA expertise

CTD/eCTD

RFI responses

Lifecycle management

Cross-functional coordination

Education

B.Pharm/M.Pharm/M.Sc.

Job description

• Prepare, review & submit Marketing Authorization Applications (MAA) to UK MHRA.
• Compile, review & submit CTD/eCTD dossiers for new product registrations.
• Ensure compliance with current UK MHRA guidelines & regulatory requirements.

Required Candidate profile

• Exp: 8–15 yrs in UK MHRA Regulatory Affairs.
• B.Pharm/M.Pharm/M.Sc.
• Expertise in MAA, CTD/eCTD, RFI responses, lifecycle management & cross-functional coordination.