regulatory affairs- data administrator in mumbai

posted
contact
randstad india
position type
permanent
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posted
location
mumbai, maharashtra
function
Pharma, healthcare & lifesciences
position type
permanent
experience
2
reference number
59948
contact
randstad india

job description

regulatory affairs- data administrator in mumbai

Duties and Responsibilities

 
  • Engage closely with Regional Regulatory Affairs and Local Operating Companies on data collection for entry into the InSight system

  • Scrutinize, ensure data accuracy, completeness and integrity in the InSight system

  • Address questions related to data collection forms and the InSight system from data owners and provide guidance on related processes as required

  • Perform data quality checks with data owners for audit related events

  • Support Regulatory Affairs stakeholders on audits, inspections, quality investigations

  • Coordinate projects on data verification activities and queries 

  • Contribute to process development and process improvement activities in AP, EMEA and globally as needed

 Preferred experience:-* Candidate should have exp of regulatory product life cycle management, query responses and support the regulatory aspects of  pre and post-approval data for the registration of Pharmaceutical products.* Regulatory submission and registration of pharmaceutical products * Maintaining the product status and on-going activities.* Query response compilation, review and submission.* Should have worked on InSight software

skills

Regulatory affairs

qualification

Any