Manager at Bangalore

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test1242
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Manager at Bangalore

Job Category     Medical/Healthcare/Bio-Tech
Location             Bangalore
Experience         9.00 to 12.00 years
Education           MPHARM, MS II

Skills    

Strong knowledge and experience in handling regulatory requirements, functions with Biologicals/API/Sold Dosage particularly with filing with USFDA and EU for the final marketing approval (NDA, ANDA) •Handling of Regulated /ROW markets and with knowledge on non-clinical, clinical and BA/BE studies with Labeling requirements, electronic submission would be an added value. •Ability to evaluate weakness and provide training and develop strategies to strengthen the weaker skills in the team.

Job Description    

  • To ensure the filing of required regulatory documents on time as per regulatory norms, take active participation from start of the project and give Regulatory strategy inputs to the team
  • Liaise with Regulatory agencies, partners, customers, agents.
  • Lead a team dedicated for a project and be a part of any Regulatory inspection.
  • Play an important role in any decision making.
  • Review of Dossiers, regulatory documents, response to deficiencies and guide team members.
  • Ensuring Good Regulatory Practices are followed within the team and also proper training is provided amongst the team members.
  • Perform Gap analysis

Deadline: Contact employer


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