Regulatory Affairs Specialist

vor 4 Wochen

Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit
Regulatory Affairs Manager (CMC)

As a key member of our team, you will play a crucial role in ensuring the compliance and quality of our medicinal products. Your expertise in global regulatory requirements will be essential in supporting the approval and maintenance of our products.

Key Responsibilities:

  • Create, review, and update high-quality CMC documentation to obtain and maintain product approvals.
  • Implement change control processes, coordinate regulatory assessments, and maintain CMC submission and approval status.
  • Handle and manage inquiries related to quality documentation from authorities, ensuring timely and accurate responses.
  • Oversee regulatory CMC projects, communicate with stakeholders, and coordinate third-party services.
  • Develop regulatory CMC strategies and represent regulatory requirements in project teams and interdisciplinary teams.

Requirements:

  • Completed scientific studies in a relevant field, such as pharmacy, biology, or chemistry.
  • 3-5 years of experience in regulatory affairs or a related field, such as analytics, development, or quality control.
  • Strong communication skills, including proficiency in English.
  • Analytical and systemic thinking, with a focus on compliance and quality.

What We Offer:

  • Individual career development in a purposeful job, improving the quality of life of our patients.
  • A hybrid work model that allows for a good work-life balance.
  • Attractive location with good transport links, modern workplaces, and a company restaurant.
  • Global family business with flat hierarchies and an open, respectful corporate culture.
  • Attractive remuneration with extensive social benefits.

Join us in our mission to improve treatment outcomes for patients around the world, reducing the burden of suffering for affected people and their surroundings.

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