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31 Zydus Lifesciences Jobs

Executive To Assistant Manager - IRA (ROW Market)

3-7 years

₹ 4 - 7L/yr

Ahmedabad

3 vacancies

Executive To Assistant Manager - IRA (ROW Market)

Zydus Lifesciences

posted 10d ago

Job Role Insights

Fixed timing

Job Description

Roles and Responsibilities:


  • Compilation and review of dossiers as per requirements for ROW Market.
  • Review of Technical Documents (EDMF, Product Development Report, BMR, BPR, Analytical Method Validation Report, Specification-STP, Stability Report, BE Study Report etc.)
  • Compilation and review of dossiers as per requirements for different Countries.
  • Compilation of deficiency responses of new product submission and Backlog dossier to submit to DI consultancy.
  • To review the proposal for any post-approval changes as per the current regulatory guidance.
  • To prepare and submit the variation for post approval changes.
  • To communicate and follow up with overseas regulatory team /agent/ distributors to ensure timely filing of new submission or variation.
  • To review various artworks & comments for ongoing commercial supply & products for the new launch.
  • To prepare and maintain various registration Data base & updating at Central Depository
  • To provide NPIF for various products for Market requirements to packing department for preparation of change part and Artworks.
  • Compilation and Review of commercial and supporting documents (1.e. Commitments, File Note, SFG-FG Linkage, FSC, LIFs, etc.)
  • To coordinate with GDSO & vendor to get DME, GMP certificate etc. for filing purp

Desired Candidate Profile

  • Should have similar experience of International Regulatory Affairs.
  • Should have good communication and interpersonal skills
  • Should have good excellent practical knowledge of regulatory submission in ROW Market.


Employment Type: Full Time, Permanent

Read full job description

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What people at Zydus Lifesciences are saying

What Zydus Lifesciences employees are saying about work life

based on 6k employees
56%
59%
47%
96%
Strict timing
Monday to Saturday
No travel
Day Shift
View more insights

Zydus Lifesciences Benefits

Submitted by Company
Cafeteria
Team Outings
Health Insurance
Job Training
Free Transport
Gymnasium +3 more
Submitted by Employees
Free Transport
Job Training
Health Insurance
Soft Skill Training
Cafeteria
Education Assistance +6 more
View more benefits

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Zydus Lifesciences Ahmedabad Office Location

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Ahmedabad Office
Headquarter
Zydus Lifesciences Limited, ‘Zydus Corporate Park’, Scheme No. 63, Survey no. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway Ahmedabad
382481

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