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Pharmaceutical Regulatory Professional

1 tydzień temu

Poznań, Greater Poland Randstad Polska Sp. z o.o. Pełny etat

We are looking for a Regulatory Affairs Specialist to join our team at Randstad Polska Sp. z o.o.

About the Role:
  • Manage multiple CMC variations and source transfers for Finished Products, Intermediates and Active Pharmaceutical Ingredients for pharmaceutical, biopharm and vaccines products (work with the CTD Module 3, Quality part of the dossiers)
  • Lead assigned projects: define and agree regulatory strategy, complete data assessment to ensure authored regulatory dossier is in compliance with GlaxoSmithKline regulatory processes and external requirements for local markets e.g. Europe (for Centralised, Mutual Recognition and Decentralised procedure submissions), US and International countries
  • Collaborate with colleagues in Global Supply Chain, Global Regulatory Groups and GSK Local Operating Companies in markets worldwide to deliver high quality dossiers on time
  • Build and maintain good relationships with internal and external stakeholders
  • Monitor regulatory intelligence and act proactively on identified changes to the regulatory requirements
  • Identify improvement opportunities for CMC Regulatory processes, policies and systems
Requirements:
  1. Relevant experience in regulatory affairs, pharmaceutical industry (familiarity with post-approval CMC regulatory procedures and ICH CTD documentation)
  2. Bachelor's or Master's degree in biotechnology, chemical technology, pharmacy, chemistry or other related science or technical field
  3. Understanding of the pharmaceutical industry, drug development environment, and regulatory processes
  4. Attention to detail with emphasis on accuracy and completeness
  5. Ability to handle multiple tasks, to meet constantly shifting priorities and to schedule work to meet business needs
  6. Flexible and analytical thinking to independently provide solutions to issues
  7. Excellent interpersonal skills; ability to communicate clearly and effectively, work in a diverse team environment and build relationships across a large organization
  8. Excellent written and verbal communication skills in English and Polish
Why Work with Us:
  • Opportunity to participate in trainings and improve skills
  • Development opportunities within the company structure
  • Flexible working hours
  • Work culture based on respect, honesty, transparency and focusing on consumer needs
  • Occasional temporary employment contract
  • RandstadPlus - a system of benefits (sports card, private medical care, discounts on online shopping)