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18 Unichem Laboratories Jobs

Officer/ Sr. Officer - Regulatory Affairs (formulations) ROW/SEA

2-5 years

Mumbai

1 vacancy

Officer/ Sr. Officer - Regulatory Affairs (formulations) ROW/SEA

Unichem Laboratories

posted 4d ago

Job Role Insights

Fixed timing

Key skills for the job

Job Description

RESPONSIBILITIES

  • Coordination with the customer to compile the dossier as per current registration regulations in SEA & East Africa markets.
  • Coordination with the customer at various registration stages to obtain approval.
  • Analyze the molecule and determination for need of Bioequivalence or bio waiver studies.
  • Life cycle management of product license by filing renewals and analyzing the type of variation needed to be based on the proposed changes to DMF, formulation, packaging, or excipients.
  • Review and approve the artworks as per Brazil and Canada market regulations.
  • Interpretate deficiencies received compile and submission responses within the stipulated time frame.
  • Maintenance of tracker for submission and deadline for responses and coordination with stakeholders to submit responses within stipulated deadlines.

DESIRED SKILLS

  • Good knowledge of Registration requirements in ROW market.
  • Experience in submission of generic medicine dossiers to the ROW market.
  • Good technical knowledge, review skills and understanding of regulatory submissions
  • Strong knowledge of CTD/ ACTD requirements for submission of dossiers to SEA , ME & AFRICA markets.
  • Good analytical and problem-solving skills.
  • Ability to try new approaches when faced with challenges.
  • Should have a good analytical and learning attitude.
  • Proactive to submission of response to any queries.
  • Good communication skills.


Employment Type: Full Time, Permanent

Read full job description

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What people at Unichem Laboratories are saying

Regulatory Affairs salary at Unichem Laboratories

reported by 2 employees with 5-7 years exp.
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₹3.6 L/yr - ₹4.7 L/yr
35% less than the average Regulatory Affairs Salary in India
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What Unichem Laboratories employees are saying about work life

based on 1.1k employees
58%
63%
53%
97%
Strict timing
Monday to Saturday
No travel
Day Shift
View more insights

Unichem Laboratories Benefits

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

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