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28 Mankind Pharma Jobs

RS/SRS- Regulatory Affairs

2-5 years

Manesar

1 vacancy

RS/SRS- Regulatory Affairs

Mankind Pharma

posted 15hr ago

Job Role Insights

Fixed timing

Job Description


  • Preparation & submission of new drug master files of drug substances in various countries as per the business requirement.
  • Preparation & submission of drug master files in electronic format (eCTD) as per the requirement.
  • Preparation & sharing of applicants part/ODMF or technical data packages of drug substances as per the market requirement to support the business of organisation.
  • Providing technical and regulatory support to sales & marketing and external customers as per the requirement.
  • Review of R&D generated documents but not limited to quality plans, specification of raw materials, in-process, intermediates or final drug substance.
  • Review of plant generated documents but not limited to change controls, blank BPR, executed BPR, protocols and reports, stability data, COAs, specification & testing procedures related to raw materials, in-process, intermediates or final drug substance etc.
  • Providing inter department regulatory support to various departments in plant and R&D centre.
  • Any other work assigned by Reporting manager and Head Regulatory Affairs time to time

Employment Type: Full Time, Permanent

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What people at Mankind Pharma are saying

What Mankind Pharma employees are saying about work life

based on 2.4k employees
53%
68%
40%
98%
Strict timing
Monday to Saturday
Within city
Day Shift
View more insights

Mankind Pharma Benefits

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

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