Regulatory Affairs Trainee in Bliss GVS Pharma "P"

Job Description:

• Preparation of Dossier in ROW Markets
  
• Reviewing documents received from QA/QC & maintaining records
  
• Searching guidelines of registration for different countries like Europe, US, Asian Countries, South Eastern countries
  
• Reviewing data (BMR, MFR, Stability data, specification Data) received from LL locations (Loan License)
  
• Co-ordinating with our plant and LL locations for samples
  
• Printing & Filing of dossier & data
  
• Arranging & checking art-works of drug products for technical accuracy, registration
  
• Collecting additional data required by Regulatory Authorities for the queries, related to Pharmaceutical and Pharmacological documents
  
• Reviewing of documents received from public labs
  
• Preparation of data like Stability, Specification & Standard Test Methods, Standard Operating Procedure, Certificate of Analysis.
  
• Visiting Mfg. Plant, LL Units & Contract manufacturing units for the data required for submission
  
• Preparing Product registration status for all countries (country wise / person wise)

Minimum Skills Required:

• Proper understanding of Pharmaceutics and Pharmacology
  
• Gen of various sites on Internet related to pharma field such as Pub Med, clinical trial, Google search, RX List.com
  
• Strong analytical skills for reviewing the documents
  
• Excellent interpersonal, verbal, and written communications skills
  
• Good computation Skills
  
• Logical Interpretation of Data
  
• Sound knowledge of MS-OFFICE
  
• Curiosity & Attentiveness in Learning
  
• Engrossment in job related work
  
• Punctual, Sincere and Systematic approach
  
• Ability to work as a team
  
• An eye for detail

Eligibility Criteria:
B. Pharm Fresher
Only Male candidates are required
Residing in and around Andheri (Mumbai)
Candidates basically from Mumbai & suburban origin only will be considered
Computer Efficacy in MS-Office and Internet

End Date: 14^th March, 2014

Send your resume at: careers@blissgvs.com