Regulatory Affairs Specialist - Duesseldorf, Deutschland - Clearstone GmbH

Clearstone GmbH
Clearstone GmbH
Geprüftes Unternehmen
Duesseldorf, Deutschland

vor 2 Wochen

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung
Our client is a world leading Pharmaceutical company, for their Munich office they're currently looking for a:

Regulatory Affairs Specialist - Munich
This role is integral to our Regulatory Affairs department, specifically catering to the European Market.

We seek a meticulous professional to oversee all regulatory affairs and quality assurance endeavors, ensuring adherence to local and international regulatory standards.


Responsibilities:


  • Establish and implement a robust quality management system within the European Regulatory Affairs (ERA) domain.
  • Identify the necessity for best practices, processes, SOPs, tools, and training sessions, facilitating the development of systemic processes.
  • Collaborate with stakeholders and internal teams to ensure regulatory compliance across the product lifecycle.
  • Provide comprehensive training and guidance to the team on regulatory and qualityrelated matters.
  • Engage in continuous improvement initiatives to bolster compliance and streamline processes.
  • Strategically plan ERA projects and systematically track their progress.
  • Offer operational support for regulatory submissions and related tasks as required.

Requirements:


  • Demonstrated aptitude for learning and adaptation.
  • Proficient in project management, with a proven track record of working efficiently under pressure.
  • Possess a positive demeanor and foster a collaborative team spirit.
  • Excellent interpersonal and communication skills.
  • Bachelor's degree or higher, preferably in pharmaceutics.
  • Minimum of 7 years of relevant work experience in regulatory affairs or GxP quality assurance.
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