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4 Concord Biotech Jobs

Regulatory Affairs Officer

0-5 years

Ahmedabad

1 vacancy

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

Read full job description

Prepare for Regulatory Affairs Officer roles with real interview advice

Top Concord Biotech Regulatory Affairs Officer Interview Questions

Q1. What is full form of CF ?
Q2. What is CAPA in GMP ?
Q3. What is Full form of GDP ?
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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
56%
66%
59%
95%
Strict timing
Monday to Saturday
No travel
Day Shift
View more insights

Concord Biotech Benefits

Free Transport
Job Training
Health Insurance
Soft Skill Training
Cafeteria
Work From Home +6 more
View more benefits

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