Dra Executive @ Nalagarh Placement

Job Description

Job responsibilities at Regulatory Affairs:

• Reviewing & Preparation of Product Dossiers for regulatory compliance in CTD/ACTD format or as per country specific requirement for Injection, Oral Solid, Semi Solid & Liquid Dosage Form for the following countries:
• Asian pacific countries Myanmar, Vietnam, Hong Kong, Philippines, Sri Lanka.
• CIS countries- Uzbekistan, Kyrgyzstan, Tajikistan.
• LATAM countries- Costa Rica, Guatemala, El Salvador, Honduras.
• African countries- Tanzania, Ivory Coast, Ghana, Uganda, Nigeria, Zambia, Francophone.
• Prepare/Review the technical documents such Product Development Report (PDR), Master Formula Record (MFR), Process Validation Protocol (PVP) and Report (PVR), Specifications (Raw material, In-process & Finished Product), Certificate of Analysis (Finish Product), Standard Testing Procedure (STP), Stability Protocols, Stability data compilation, COPP (Certificate of Pharmaceutical Products) applications, Drug Master File (DMF) etc.
• Prepare/Review of SPC & Package Insert.
• Co-ordinate with plant - production & packing for samples and documents.
• To check & co-ordinate with licensing department for COPP (Certificate of Pharmaceutical Products) applications.
• Respond to queries from health authorities or customers within predefined time with adequacy and accuracy.
• To study and update Regulatory guideline of assigned countries and to prepare checklist / template for registration dossier.
• To collect and verify all technical documents and information from various departments at the manufacturing site and R & D site.
• Regulatory support to various departments.
• Co-ordinate & follow-up with manufacturing locations for Registration samples, WS and Impurities.
• To maintain and update Registration certificate /information in regulatory data base.
• Leading a Team, Guide & Solve the problems and queries of sub-ordinates.
• Interact effectively with other departments e.g. QA, QC, Production & Marketing etc.

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Rs 0 - 50K PM Rs 50K - 1 LPA Rs 1.0 - 1.5 LPA Rs 1.5 - 2.0 LPA Rs 2.0 - 2.5 LPA Rs 2.5 - 3.0 LPA Rs 3.0 - 3.5 LPA Rs 3.5 - 4.0 LPA Rs 4.0 - 4.5 LPA Rs 4.5 - 5.0 LPA Rs 5 - 6 LPA Rs 6 - 7 LPA Rs 7 - 8 LPA Rs 8 - 9 LPA Rs 9 - 10 LPA Rs 10 - 12 LPA Rs 12 - 14 LPA Rs 14 - 16 LPA Rs 16 - 18 LPA Rs 18 - 20 LPA Rs 20 - 22 LPA Rs 22 - 24 LPA Rs 24 - 26 LPA Rs 26 - 28 LPA Rs 28 - 30 LPA Rs 30 - 32 LPA Rs 32 - 34 LPA Rs 34 - 36 LPA Rs 36 - 38 LPA Rs 38 - 40 LPA Rs 40 - 42 LPA Rs 42 - 44 LPA Rs 44 - 46 LPA Rs 46 - 48 LPA Rs 48 - 50 LPA Rs 50 - 75 LPA Rs 75 Lakh - 1C PA Rs 1 Crore+ PA

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