Regulatory Affairs Associate

FERRING PHARMACEUTICALS AS

Istanbul, Turkey
Document accountable person responsibilities
Regulatory submissions and dossier preparation
Experience with e-ctd and veeva vault systems
The role involves serving as the Document Accountable Person and Controller to ensure document lifecycle management and compliance

Job Summary

  • The role involves serving as the Document Accountable Person and Controller to ensure document lifecycle management and compliance.
  • Candidates will coordinate new drug approvals, manage regulatory submissions, and support product lifecycle activities in line with local regulations.
  • Ferring Pharmaceuticals offers an inclusive support package called 'Building Families at Ferring' providing equal policies for all employees.

Matching Summary

The role involves serving as the Document Accountable Person and Controller to ensure document lifecycle management and compliance.

Skills & Requirements

Must-have

  • Document Accountable Person responsibilities
  • Regulatory submissions and dossier preparation
  • Experience with e-CTD and Veeva Vault systems
  • Local regulatory authority interactions
  • Quality assurance and document lifecycle management

Nice-to-have

  • Track Wise pricing data monitoring experience
  • Eager to learn personality
  • Team player approach with attention to details
  • Fluent in English language written and verbal

Key Requirements

  • University degree in Pharmacy
  • Minimum 2-3 years practical experience in regulatory and quality assurance
  • Experience with interactions with regulatory authorities

Work Rights

Not specified

Tailored Resume

Cover Letter