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17 Apotex Research Jobs

Regulatory Affairs Executive

3-6 years

Bangalore / Bengaluru

2 vacancies

Regulatory Affairs Executive

Apotex Research

posted 1d ago

Job Description

Roles and Responsibilities

  • Prepare dossiers, variations, renewals, and amendments for regulatory submissions.
  • Coordinate with CTD/eCTD vendors for preparation of dossiers.
  • Review artwork, labeling, and specifications for regulatory compliance.
  • Maintain master files and variation records according to ICH guidelines.
  • Ensure timely submission of applications to relevant authorities.

Desired Candidate Profile

  • 3-6 years of experience in Regulatory Affairs (dossier preparation & submission).
  • Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma) from a recognized institution.
  • Strong understanding of Life Cycle Management (LCM), Product Lifecycle Management (PLCM), OSD regulations.

Employment Type: Full Time, Permanent

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What people at Apotex Research are saying

5.0
 Rating based on 1 Executive Regulatory Affairs review

Likes

Good work culture but many internal politics

  • Skill development - Excellent
  • +4 more
Dislikes

Not providing good percentage of promotion/increment

Read 1 Executive Regulatory Affairs review

Executive Regulatory Affairs salary at Apotex Research

reported by 5 employees with 4-7 years exp.
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₹5.2 L/yr - ₹8 L/yr
37% more than the average Executive Regulatory Affairs Salary in India
View more details

What Apotex Research employees are saying about work life

based on 788 employees
51%
91%
69%
98%
Flexible timing
Monday to Friday
No travel
Day Shift
View more insights

Apotex Research Benefits

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

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