Manager - Regulatory Affairs

Julphar Net Corp

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On-site
Life cycle management
Regulatory authorities dialogue
Dossier database maintenance
Julphar Net Corp is seeking a Manager of Regulatory Affairs to oversee the operational implementation of submission and approval plans for drug products across various markets. The ideal candidate should have a Bachelor of Pharmacy, at least 10 years of experience in regulatory affairs, and a strong understanding of global regulatory requirements

Job Summary

  • Responsible for the day-to-day operational implementation and execution of the submission/approval plans of the markets where Julphar is operational.
  • Lead & strength the life cycle management team in terms of technical and scientific aspects to overcome the dynamic regulatory challenges worldwide.
  • Collaborate with PDL, QA, QC, Tender, Marketing and Accounts Departments to gather the relevant information required for submissions.

Matching Summary

Match Score: 85

Julphar Net Corp is seeking a Manager of Regulatory Affairs to oversee the operational implementation of submission and approval plans for drug products across various markets. The ideal candidate should have a Bachelor of Pharmacy, at least 10 years of experience in regulatory affairs, and a strong understanding of global regulatory requirements.

Skills & Requirements

Must-have

  • life cycle management
  • regulatory authorities dialogue
  • dossier database maintenance
  • regulatory strategy provision
  • pharmaceutical development understanding

Nice-to-have

  • culture transformation journey
  • positive impact on patients
  • healthy work environment

Key Requirements

  • Bachelor of Pharmacy with min 10 years of experience
  • Proficient PC Skills: Word, Excel; knowledge of SAP software
  • Applied understanding of specific regulatory discipline
  • Full functional knowledge of regulatory requirements
  • Excellent organization skills and ability to manage multiple projects

Work Rights

Not specified

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