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Senior Regulatory Specialist CMC

Termin ważności:
2020-09-02 - 2020-10-02
Województwo / region:
Warszawa, mazowieckie
Firma:
ukryte

Responsibilities:


  • Managing multiple CMC (Chemistry, Manufacturing and Control) Variations assignments for Finished Products and Active Pharmaceutical Ingredients

  • Define and agree strategy, complete data assessment to ensure authored regulatory dossier is in compliance with the company regulatory processes and external requirements for local markets e.g. Europe (for Centralised, Mutual Recognition and Decentralised procedure submissions, US and International countries)

  • Working with colleagues in Global Manufacturing & Supply and Local Operating Companies in markets worldwide to deliver high quality dossier on time

  • Act as subject matter expert in regulatory processes

  • Ensuring all appropriate regulatory aspects for product release and stability are in place, to ensure continuity of market supply

  • Monitoring regulatory intelligence and act proactively on identified changes to regulatory requirements

  • Building good relationships with internal and external stakeholders


Requirements:

  • Experience (in regulatory affairs, pharmaceutical industry, life sciences research, clinical research, pharmacovigilance)

  • Bachelor’s degree in biotechnology, pharmacy, chemistry or other related science or technical field

  • Attention to details, excellent organization and time management skills

  • Excellent written and verbal communication skills in English and Polish

  • Ability to think flexibly in order to meet constantly shifting priorities and timelines and to independently provide solutions to issues

  • Well-developed understanding of the pharmaceutical industry, drug development environment

  • Well-developed understanding of regulatory process (e.g. experience in managing CMC global Variation Projects)


We offer:

  • Established job in an international, well-known pharmaceutical company

  • Opportunity to work in professional team

  • Wide range of benefits

  • Annual bonus

  • Flexible working hours

  • Partly remote work

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