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...
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,...
Central Drugs Standard Control Organisation (CDSCO) FDA Bhawan, New Delhi
RS Up To 3,25,000 Hyderabad, Sector 18 Chandigarh, South Delhi, East Delhi, Central Delhi, Mohali, 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
- Reviewing Doc From Adl, R&D, Quality & Prod.
- Life Cycle Management Through Amendments / Annual Reports.
- Managing Databases And Up-Keeping Of Recording Systems
- Preparation And Reviewing Of Regulatory Dmf.
- Response To Customer Dmf...
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
Candidate with 3-5 year of experience in regulatory filing for ROW and Semi- regulated marked for Injectable Formulation.
Advantage if handled eCTD submission and exposure of Regulated Market and other Dosage form.
Should be capable of handling...
Strong With Regulatory Documentation
Mfr/Sop/Amv(Analytical Method Varidation),Actd/Ctd, Dossier Preparation
Having A Sound Knowledge Of Bmr Preparation And Filing, Fr&D Documentation, Pv Etc
Will Be Responsible For Handling Regulatory Affai...
Given in an opportunity to work closely within a Pharmaceutical & Biotechnology consulting company, you will be able to catalyze the organizational growth by providing regulatory in-sights for specific products for Indian market.