Regulatory Affairs Specialist

il y a 4 semaines


BoulogneBillancourt, Île-de-France Incyte Temps plein
Job Summary

As a Regulatory Affairs Associate at Incyte, you will play a crucial role in ensuring compliance with local and European legislation in pharmaceutical affairs, regulatory affairs, pharmacovigilance, and quality assurance. Your primary responsibilities will include managing regulatory activities, monitoring communication documents, and participating in pharmacovigilance activities.

Key Responsibilities
  • Manage regulatory activities specific to an Exploitant company for products distributed by Incyte Biosciences France.
  • Monitor and control communication documents, including regulatory validation, submission to authorities, and document management.
  • Participate in pharmacovigilance activities, in collaboration with the Local QPPV.
  • Contribute to the training of Incyte Biosciences France employees.

Requirements
  • Doctor in pharmacy or equivalent, registerable in section B of the Order of Pharmacists.
  • Previous experience in pharmaceutical affairs, preferably in an Exploitant company.
  • Excellent problem-solving skills, perfect communication skills, and discretion when handling sensitive information.
  • Proficiency in Office software systems (Excel, Word, PowerPoint) and Outlook.
  • French and Scientific and technical English mandatory.

Disclaimer
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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