Regulatory Affairs Executive

Centaur Pharmaceuticals; Mumbai; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Centaur Pharmaceuticals is seeking a regulatory affairs professional with 4-8 years of experience in ROW markets (LATAM, Africa, South East Asia, MENA, GCC). The role involves compiling dossiers, responding to regulatory queries, and managing post-registration variations.

You will coordinate with QA, QC, R&D, marketing, analytical development labs, manufacturing, and admin to collect and submit required documentation, including tender documents and artworks.

Qualifications

• 4-8 years experience in ROW markets (LATAM/Africa/S.E. Asia/MENA/GCC).
• Ability to prepare and submit dossiers in CTD/ACTD formats.
• Coordinate with QA, QC, R&D, Marketing, Analytical, Manufacturing, Admin.

Responsibilities

• Compile and submit Fresh & Renewal dossiers for ROW registrations.
• Prepare and respond to regulatory authority queries.
• Submit post-registration variations.
• Prepare company registration documents per country requirements.
• Coordinate with internal departments for technical documents.
• Compile and check tender documents.
• Coordinate with art department for artworks.
• Arrange and courier registration samples.

Skills

Regulatory submissions

Cross-department coordination

Documentation

Education

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

Job description

Qualification: M.Pharm /B.Pharm/M.Sc. having 4-8 years experience in ROW markets- LATAM/ AFRICA/ SOUTH EAST ASIA/ MENA/ GCC

• Compilation and submission of Fresh & Renewal dossiers for registration in ROW countries based on CTD/ACTD/Country specific format for different dosage forms.
• Preparation and submission of query response raised by regulatory authority.
• Preparation and submission of post-registration variations
• Preparation and submission of Company Registration Documents as per the country requirements.
• Co-ordination with various departments such as Quality Assurance, Quality Control, R & D, Marketing Department, Analytical development labs, Manufacturing plant, Administrative department etc. for collection of various technical documents as required for registration.
• Compilation and Checking of Tender Documents.
• Co-ordination with art department for Artworks.

Arrange & Courier the registration samples