| Designation | Drug Regulatory Affairs - Officer/Asstt. Manager |
| Job Description | 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. |
| Desired Profile | Thorough knowledge of FDA regulation of India and Third Countries ,Drugs and Cosmectics Acts and rules of India and also regulatory guidelines. •Must be from Science / Pharmacy background with Min 2 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 initiator , keen learner , proactive and good analytical skills • Should have pleasing and presentable personality. • Candidate from South Delhi, Central Delhi and Faridabad will be preferred more. |
| Experience | 3 - 7 Years |
| Industry Type | Pharma/ Biotech/Clinical Research |
| Role | Regulatory Affairs Mgr |
| Functional Area | Healthcare, Medical, R&D |
| Education | UG - B.Pharma - Pharmacy,B.Sc - Any Specialization PG - M.Pharma - Pharmacy |
| Compensation: | Rupees 3,00,000 - 4,50,000 |
| Location | Delhi/NCR |
| Keywords | DRA, Regulatory, Documentation, Regulatory Affairs, Sr. Regulatory Executive, Registration,Import Licensing,Export Licensing,DCGI,CDSCO,FICCI. |
| Contact | Ms. Sujata |
| Telephone | 91-11-40651100 |
| Website | http://:unitedbiotechindia.com |
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