• Managing activities related to Regulatory Affairs and Regulatory Compliance. Set up, evaluate, follow up and maintain regulatory dossiers (CMC) for submission.
• Maintain up to dated documentation by the respective authorities in CTD / eCTD / ACTD and country specific formats based on statutory requirements.
• Consolidate documents and responses/statements for processing deficiency reports or due to regulatory inquiries including regulatory and pharmaceutically relevant documents and contracts.
• Rollout and ensure compliance to regulatory changes or requirements. Set up and process documents from contract manufacturers, conduct quality check on the documents to comply with the regulatory requirements.
• Interact with manufacturers/clients/customers to align with the dossiers for Global Regulatory submissions, for the submission of queries received from respective regulatory bodies.
• Assessed labeling and packaging of drug products. Evaluated labeling and packaging materials, Summary of Product Characteristics (SmPC) and Package Inserts.
• Maintain updated knowledge of changes in regulatory legislation and guidelines.
• Ensured compliance to standards, procedures and policies for submissions set forth for the Regulatory Function including Company’s submission standards, policies and procedures.
ملحوظة هامة:
وظايف نت ليست شركة توظيف وانما موقع للاعلان عن الوظائف الخالية المتاحة يوميا فى أغلب الشركات بالشرق الاوسط
,فنرجو توخى الحذر خاصة عند دفع اى مبالغ او فيزا او اى عمولات. والموقع غير مسؤول عن اى تعاملات تحدث من خلال الوظائف المعلنة.
