Global Regulatory Affairs Specialist

vor 9 Stunden

Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit
Company Overview

Miltenyi Biomedicine is a biopharmaceutical company pioneering groundbreaking therapies for serious life-threatening diseases. Our mission is to advance personalized cell and gene therapies, improving and extending patients' lives worldwide.

Salary

The estimated annual salary for this position ranges from $120,000 to $180,000, depending on experience and qualifications.

Job Description

We are seeking a highly skilled Regulatory Affairs representative to manage investigational and approved advanced medicinal therapy products on a national or international basis. This includes operational responsibility for one or more products, providing regional regulatory strategy and planning, and coordinating with health authorities to ensure compliance.

  • Manage the development and maintenance of prescribing information and risk management plans.
  • Contribute to relevant aspects of product safety and quality regarding pharmacovigilance and regulatory requirements.
Required Skills and Qualifications

To succeed in this role, you will need:

  • A degree in pharmacy, biology, chemistry, or a related field (M.D., Ph.D., or equivalent).
  • Several years of relevant experience in EU regulatory affairs, drug development, and/or submission management with a focus on ATMPs and biologics.
  • Sound business judgment, collaborative skills, and proven ability to interact and influence at all levels of a dynamic organization.
  • Excellent organizational and communication skills in English, with basic German skills preferred but not required.
Benefits

As a member of our team, you can expect:

  • A modern workplace in Bergisch Gladbach with opportunities for mobile work.
  • Exciting opportunities in technology development with a secure future.
  • Cross-border intercultural cooperation and short communication channels.
  • A collegial corporate culture and flexible working hours enabling time management on your own terms.
  • Diverse corporate benefits regarding employee health, sport, and staff events.
Others

If you are a self-starter with excellent organizational and communication skills, we encourage you to apply for this exciting opportunity. Please submit your application, including your salary expectations and availability.

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