Senior Regulatory Specialist, Small Molecules Mature Products, CMC, Global Regulatory Affairs – Delivery Team

Senior Regulatory Specialist, Small Molecules Mature Products, CMC, Global Regulatory Affairs – Delivery Team

GSK

Standort

Hexjobs Insights

Senior Regulatory Specialist – CMC: zarządzanie projektami CMC, przygotowywanie dokumentacji CTD, współpraca z Global Supply Chain i zespołami regulacyjnymi; wymagana wiedza z regulacji farmaceutycznych oraz wykształcenie w biotechnologii lub pokrewnej.

Schlüsselwörter

Senior Regulatory Specialist
CMC
regulatory affairs
CTD Module 3
pharma
Warszawa

Vorteile

  • program MyBenefit
  • dofinansowanie aktywności sportowych
  • prywatna opieka medyczna
  • ubezpieczenie na życie
  • elastyczny czas pracy
  • plan emerytalny
  • miejsce parkingowe
  • dodatkowe świadczenia socjalne
  • dofinansowanie biletów do kina i teatru
  • fundusz urlopowy
  • program poleceń pracowniczych

Anforderungen

Bachelor’s or Master’s degree in biotechnology, chemical technology, pharmacy, chemistry, or another related science or technical field., Relevant experience in regulatory affairs (the pharmaceutical industry), with familiarity in post-approval CMC regulatory procedures and ICH CTD documentation (Modules 2 and 3)., Understanding of the pharmaceutical industry, drug development environment, and regulatory processes., Thorough understanding of change management processes and regulatory requirements., Attention to detail with an emphasis on accuracy and completeness., Ability to handle multiple tasks, meet shifting priorities, and schedule work to meet business needs., Flexible and analytical thinking to independently provide solutions to issues., Excellent interpersonal skills, including the ability to communicate clearly and effectively, work in a diverse team environment, and build relationships across a large organization., Excellent written and verbal communication skills in English.

Vorteile

program "MyBenefit, sharing the costs of sports activities, private medical care, life insurance, flexible working time, retirement pension plan, parking space for employees, extra social benefits, sharing the costs of tickets to the movies, theater, holiday funds, employee referral program

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Aufrufe: 8
Veröffentlichtvor 16 Tagen
Läuft abin 14 Tagen

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