Regulatory Affairs Manager

Regulatory Affairs Manager

Merz Pharma

Frankfurt, Germany

THESE TASKS ARE WAITING FOR YOU:

  • Ensure and apply the regulatory knowledge for the assigned regions and countries to create high-quality documentation
  • Carry out registration procedures and ensure compliance with internal requirements
  • Implementation and support of regulatory activities for preparation and submission of applications for new registrations, approval dossiers and GMP verification of the documentation in accordance with national regulatory requirements
  • Coordination and implementation of change control processes and continuously tracking and maintaining the CMC submission and approval status
  • Ensure worldwide labeling compliance by updating national product information texts and packaging materials according to company core data sheets, national requirements and internal processes
  • Optimization of internal work processes and structures by cooperating with Merz departments and external partners worldwide
  • Ensure all regulatory life cycle management activities and timely responses to authorities’ inquiries
  • Coordination of regulatory projects with the respective stakeholders and support regulatory strategies
  • Preparation and participation in scientific consultations with regulatory authorities worldwide

THIS IS WHAT WE EXPECT FROM YOU:

  • Pharmacist or PhD in natural sciences or comparable academic background
  • At least 4 years of regulatory experience in medicinal products in the pharmaceutical industry in a similar position
  • Experienced in registration or marketing authorization of medicinal products and itslife cycle management in non-EU countries
  • Business fluent in German and English language
  • Creative mindset and innovative thinking and problem-solving skills
  • Excellent communication skills, flexibility and perseverance
  • Professional user skills of standard software business applications

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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