Review and Submission of Drug Master File (DMFs) for US, EU & Japan, Submission of Certificate of Suitability (CEPs) dossier for EDQM, DMFs for Health Canada and Updates.
Handling of deficiencies raised by FDA during the course of reviewing of the...
Central Drugs Standard Control Organisation (CDSCO) FDA Bhawan, New Delhi
RS Up To 3,25,000 Hyderabad, Sector 18 Chandigarh, Mohali ( Chandigarh ), South Delhi, East Delhi, Central Delhi, Roorkee, Delhi
Import & Registration Division:
•Scrutinize & examine the Drug Master Files (DMF), Plant Master File (PMF), GMP certificates & COPP etc. from overseas manufacturing units pertaining to Registration & Import License of Drugs, under Form 41, a...
Key Skills : drug regulatory affair,clinical research,epidemilogist,pharmacovigilance,technical documents
RS 22,50,000 To 50,00,000 & above China, Weihai,Shandong
1:Handling of Tablets, Capsules, Oral Liquids and Oral Suspensions.Handling of Injectable Liquid and Lyophilized Formulations.Knowledge about the handling of Cytotoxic materials.Knowledge about the safety aspects.Knowledge about GLP and GMP.Knowledge...
Key Skills : drug analysis,development,r&d,lab,formulation,regulatory affairs
RS 2,00,000 To 3,50,000 Dehradun, Haridwar, Roorkee
Medicinal products, pharmaceuticals, veterinary medicines, medical devices, and food supplements – all these products are subject to regulations designed by governments to protect public health. The Regulatory Affairs departments of life-science co...
Key Skills : drug regulatory affair,regulatory affair,legal officer
Coordination with departments for dossier planning, preparation & approval as per Country Guidelines, Query Handling, Art Work Review, Registration process of products in new countries, Impartation of trainings ICH, CTD & ACTD Guidelines etc.
Key Skills : ctd,actd,ich,dossier,art work review,registration of products,pharmacist,pharmacy manager,pharmacy incharge,pharma associate
Synapse Clinical Research Foundation (SCRF), Delhi NCR
Synapse Clinical Research Foundation (SCRF), a non-profit organization promoting transparent, accountable and ethical conduct of clinical trials in India for patient's welfare since 2005. SCRF i...
Key Skills : clinical associate,clinical assistant,senior clinical research associate
-Heading API Regulatory section, Planning and execution of RA activities.
-Evaluation of changes in pharmacopoeias with respect to APIs manufactured and making necessary changes/inclusion in related documents.
-Interaction with cross functional te...
We are looking for Customer Sales Representative for our client in pharmaceutical industry to sell their online pharma courses and trainings.
The candidate should have experience of handling and making (inbound/outbound) calls to prospective custome...
Hiring Life Science Graduates with experience and TRAINED in CRA/CRO/CDM/PV/Regulatory
• Any Life Science graduate with an exposure to Clinical research domain
• Having a prior exposure/experience in Clinical document management/ Clinical d...
Key Skills : clinical data coordinator,clinical research associate,clinical research analyst,clinical data management,pharmacovigilance,medical coding,regulatory,...
Assist with the case processing, submission, tracking and maintenance of individual case safety report and medical device report documents involving approved products.
Assist with the processing, submission, tracking and maintenance of safety report...
RS 1,25,000 To 2,50,000 South Delhi, West Delhi, Delhi
- Preparation of dossier in CTD/ACTD format, Analytical skills for evaluating technical documents.
- Communicating with the different department of Manufacturing Unit (QA, QC,Production etc)
- Handling of NOD / resolving query