Employer Egypt Otsuka Pharmaceutical Company
Job Title Regulatory Affairs Coordinator
Country Egypt
Job Category Pharmacy
Job Type Full Time
Description - Manage Company product licenses/registrations from initial submission/approval and throughout the product life cycle. - Dossier Submission and product Approval: - Market-specific file compilation, preparation of market-specific documents e.g. application forms, summary sheets and clarification letters. - Executes the agreed plans by coordinating dossier submission through distributors in local market within planned timelines and obtain Drug Regulatory Agencies approvals for new chemical entities (NCEs), line extensions , new indications and site registration to meet the launch plans - Ensure submitted product documents will fully meet the local regulatory requirements.
Qualifications • B.ch of pharmacy • Fresh graduate of 1 year of experience • Being analytical and accurate. • High observation skills • Has good English and computer skills • Ability to solve complex problems and effective communication skills.
Gender Any
Experience 1 - 2 Years.
Salary (L.E.) Negotiable
Comments hr.communication@egyptotsuka.com
Job Title Regulatory Affairs Coordinator
Country Egypt
Job Category Pharmacy
Job Type Full Time
Description - Manage Company product licenses/registrations from initial submission/approval and throughout the product life cycle. - Dossier Submission and product Approval: - Market-specific file compilation, preparation of market-specific documents e.g. application forms, summary sheets and clarification letters. - Executes the agreed plans by coordinating dossier submission through distributors in local market within planned timelines and obtain Drug Regulatory Agencies approvals for new chemical entities (NCEs), line extensions , new indications and site registration to meet the launch plans - Ensure submitted product documents will fully meet the local regulatory requirements.
Qualifications • B.ch of pharmacy • Fresh graduate of 1 year of experience • Being analytical and accurate. • High observation skills • Has good English and computer skills • Ability to solve complex problems and effective communication skills.
Gender Any
Experience 1 - 2 Years.
Salary (L.E.) Negotiable
Comments hr.communication@egyptotsuka.com
