You are hereJob as Drug Regulatory Affairs - Officer/Asstt. Manager at United Biotech

Job as Drug Regulatory Affairs - Officer/Asstt. Manager at United Biotech

              UNITED BIOTECH

Job as Drug Regulatory Affairs - Officer/Asstt. Manager

About Company,
UNITED BIOTECH, a leading Pharma Company has carved out a distinct niche for itself as a pioneer company introducing new products to the Indian pharmaceutical industry year after year.
Has technical & marketing Tie-ups with some of the top multinationals across the globe such as:
Esseti Farmaceutici SpA-Italy Recip AB-Sweden Laboratorios Eron S.A.
Fada Pharma S.A.-Argentina Kedrion SpA-Italy Hardis SpA-Italy
The company has its own manufacturing in a "state-of-art" WHO-cGMP approved, UKMHRA, USFDA & TGA(Australia) compliant facility. The plant is ISO 9001:2000 certified & GMP:Schedule M approved.
UNITED BIOTECH’s Research Center is an additional feather in our cap,where teams of our in-house scientists are developing NDDS (Novel Drug Delivery Systems) & new products.

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.

Candidate 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.

Additional Information:
Experience: 3-7 years
Location: Delhi
Education: B.Pharm, M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA

To Apply/Send your resume,




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