Title: Executive / Sr. Executive - Global Regulatory Compliance
Company Name: Eskayef Pharmaceuticals Ltd.
Vacancy: --
Age: At least 24 years
Job Location: Dhaka (Banani)
Salary: --
Experience:
B. Pharm / M.Pharm from a reputed university
2-3 years of experience in ANDA or MA submission will be preferred
Eskayef Pharmaceuticals Ltd. is one of the fastest growing pharmaceutical companies in the country. Eskayef prides itself on being the pioneer pharmaceutical company in Bangladesh that has the approval of US FDA, UK MHRA, EU GMP, TGA Australia, VMD UK, Brazil ANVISA & South Africa SAHPRA.
Job Responsibilities:
Preparation and submission of regulatory dossiers (CTD/eCTD/Country Specific)
Prepare, review, and maintain regulatory documents for international markets
Coordinate with Quality Assurance (QA), Quality Control (QC), Production, R&D, and Supply Chain to resolve regulatory compliance issues
Assist during regulatory inspections and partner audits by preparing required documentation and responding to observations
Monitor updates in global pharmaceutical regulations and assess their impact on company operations
Maintain regulatory databases and ensure timely renewals, variations, and product registrations
Attractive package at the top of the industry
A supportive environment with world-class training & international exposure to bring out the best in our people
Excellent work culture, team spirit & performance recognition schemes
Rapid career advancement and personal development for all high potential individuals