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3.4

based on 233 Reviews

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9 Bal Pharma Jobs

DMF Preparation Specialist API

7-10 years

₹ 6 - 7L/yr

Gurgaon / Gurugram

1 vacancy

DMF Preparation Specialist API

Bal Pharma

posted 20hr ago

Job Description

  • DMF Preparation & Submission:
  • Prepare, compile, and review Drug Master Files (DMFs) for Active Pharmaceutical Ingredients (APIs) in compliance with regulatory guidelines (USFDA, EDQM, TGA, etc.).
  • Submit DMFs to regulatory agencies and address queries efficiently.

  • Regulatory Compliance:
  • Ensure all documentation adheres to ICH, WHO, and country-specific requirements.
  • Maintain an updated knowledge of current regulatory trends and guidelines.

  • Data Management:
  • Coordinate with R&D, production, and quality assurance teams to gather and validate required technical data.
  • Organize and maintain records of submitted DMFs and related communications

  • Stakeholder Coordination:
  • Liaise with customers and regulatory authorities for updates and clarifications regarding DMF submissions.
  • Support internal teams during regulatory inspections and audits.

  • Continuous Improvement:
  • Implement best practices for DMF documentation and enhance processes for efficiency and accuracy.




Employment Type: Full Time, Permanent

Read full job description

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People are getting interviews at Bal Pharma through

(based on 8 Bal Pharma interviews)
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Company Website
36%
25%
13%
13%
13% candidates got the interview through other sources.
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What people at Bal Pharma are saying

What Bal Pharma employees are saying about work life

based on 233 employees
65%
66%
46%
96%
Strict timing
Monday to Saturday
No travel
Day Shift
View more insights

Bal Pharma Benefits

Job Training
Health Insurance
Soft Skill Training
Team Outings
Free Transport
Child care +6 more
View more benefits

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