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4 Concord Biotech Jobs
Regulatory Affairs Officer
Concord Biotech
posted 1mon ago
Job Role Insights
Fixed timing
Job Description
- Well versed with Compilation, review, amend and submission of Drug Master files to various regulatory authorities i.e. US, EUROPE, Canada & other countries as per schedule and customer requirements
- Able to review and update CEP dossier for the submission to EDQM
- Able to review queries of FDA, EDQM, regulated and non regulated markets
- Know how to review and make necessary corrections in validation documents such as process validation, AMV of assay, related substance, residual solvents etc,
- Able to review and update TDP, STP of raw materials, finished products and packing material to support regulatory queries
- Able to review the changes affected to the regulatory submission and to check the impact on the regulatory filling through change control document
- Able to submit DMF in eCTD, Query response and other regulatory documents through various platforms such as ESG, CESP, EMA gateway etc.
- Review and submission of Life Cycle management of DMFs(Variations/Amendments/Annual Updation /Quin-Annual) as per schedule
- To lead and provide guidance and trouble shooting of technical activities related to Quality control and quality assurance.
- Responsible for responding to the FDA and liaison with US and European regulatory authorities
Employment Type: Full Time, Permanent
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What people at Concord Biotech are saying
Regulatory Affairs Officer salary at Concord Biotech
reported by
4
employees
₹2
L/yr - ₹2.5
L/yr
35%
less
than the average Regulatory Affairs Officer Salary in India
View more details
What Concord Biotech employees are saying about work life
based on 281 employees
Strict timing
Monday to Saturday
No travel
Day Shift
Concord Biotech Benefits
View more benefits
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