Dra Executive
- Nalagarh Placement
- 2 to 7 Yrs
- Baddi
- 5 years ago
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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.
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: Pharmacist / Medical Representative
Functional Area: Not Applicable
Role/Responsibilies: Dra Executive
Contact Details:
Company: Nalagarh PlacementLocation(s): Baddi
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₹ 2.5 - 5 Lakh/Yr
Nalagarh Placement
hiring in limited pharmaceuticals company in Baddi location. the qc department Hplc if anyone interstd plz send the cv on this id placement pharma2014@gmail.com
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