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Assistant Manager - DRA - South Africa- Mumbai

7.00 to 12.00 Years   Thane, Mumbai City   22 Jul, 2022
Job LocationThane, Mumbai City
EducationNot Mentioned
SalaryRs 6 - 14 Lakh/Yr
IndustryPharma / Biotech
Functional AreaR&D / Product Design
EmploymentTypeFull-time

Job Description

    Leading Pharma CompanyOpening in a leading Pharma CompanyDesignation - Assistant Manager - DRA - South Africa- MumbaiPreparation of quality dossier with regulatory compliance with respect to country requirement for regions- as per MOH guidelines and latest CTD, ECTD & Checklist format.Responsible for Compilation, submission and keeping record of Registration Dossiers.Variation and Notification filling as per country guideline requirementsTracking & submitting documents for renewal of registration certificateReview of technical documents such as BMR, Process Validation Report, Analytical Method Validation Report, Stability Study Report and all other documents pertaining to product registrationSynchronize with various departments (production, quality control, and quality assurance, R & D, F&D) to collect required input for timely regulatory submission of products. Application of legal documents such as manufacturing license, Certificate of Pharmaceutical Products, Free Sale certificates etc required for registration Responsible for getting the FDA documents legalized from Notary, Mantralya, Chamber of commerce and Embassies of respective countriesRegards,PriyankaExtrius Consultants & Serviceshidden_mobileEmail : hidden_email

Keyskills :
dossier preparationdrug regulatory affairsdra

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