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Easebiz Fintech Solutions
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Senior Regulatory Affairs Officer

Senior Regulatory Affairs Officer

Easebiz Fintech Solutions

5 - 10 years

|

3 - 8 Lacs

Posted:9 hours ago| Platform:

Apply

Skills Required

regulatory affairs ctd bioequivalence parenteral latam africa ent row actd pacific region ectd

Work Mode

Work from Office

Job Type

Full Time

Job Description

Key Responsibilities

Prepare, review, and submit CTD/ACTD/eCTD dossiers for international markets
Develop and execute regulatory strategies for ROW, LATAM, SEA, Africa, and Pacific regions
Manage product registration, renewals, variations, and post-approval compliance
Ensure compliance with WHO-GMP, ICH, and country-specific regulatory guidelines
Coordinate bioequivalence studies and relevant documentation
Review technical files and maintain up-to-date regulatory documentation
Liaise with regulatory authorities, internal departments, and external partners
Mentor junior RA team members and drive process improvements

Requirements

B.Pharm / M.Pharm / Life Sciences background
Minimum 6 years experience in Regulatory Affairs within the pharmaceutical industry
Proficient in CTD/ACTD/eCTD dossier compilation
Experience with parenteral dossiers (preferred)
Exposure to global regulatory submissions and product lifecycle management
Proficient in MS Office, with strong communication and leadership skills

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