Job as DRA Manager at United Biotech
United Biotech has been a trend setter of new standards and is among the fastest growing companies in the Indian pharmaceutical Industry. In a span of 12 years it has established an enviable reputation and track record for adopting latest manufacturing technologies, introducing world-class quality of products, ground breaking Research & Development efforts in association with its foreign counterparts and for setting new standards of customer service.
Post: DRA Manager
* Preparation, Review and submission of Technical documents/Dossiers (CTD/eCTD) related to Regulatory affairs for third country Export of Pharmaceuticals Formulations.
* Preparation and Review of SOPs.
* Compilation of Validation Protocols/Reports.
* Preparation,Review,Submission of Technical and other Documents/Dossiers with Drug Controller General of India/CDSCO/State FDAs for-
* Registration for import of pharmaceuticals Formulations and bulk drugs.
* Import Licenses
* Export Licenses
* Manufacturing & Marketing licenses
* WHO-GMP Certification
* No Objection Certificates etc.
* Liasioning with DCGI/CDSCO/state FDA offices/Directorate General of Foreign Trade /FICCI/PHD Chamber of Commerce etc.
* Knowledge of FDA regulation of India and Third Countries, Drugs and Cosmetics Acts and rules of India and also regulatory guidelines.
* Candidates having experience in Dossier preparation & commercial operations will be preferred.
* Experience of plant in QA/QC department will be desirable and candidate should have Science / Pharmacy background with Min 6 Years of experience in same line.
* Excellent command over written and verbal english communication.
* Must be Proficient in Computer skills and business communication.
* Should be self motivated and result oriented.
* Should be a initiator, keen learner, proactive and possess good analytical skills.
* Should have pleasing and presentable personality.
* Candidate from South Delhi, Central Delhi and Faridabad will be preferred.
Experience: 6-10 years
Education: B.Pharm, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Human Resource Department
United Biotech Pvt Ltd
FC/B-1 ( Ext ) Mohan Co-operative Industrial
Estate Mathura Road
NEW DELHI,Delhi,India 110044
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