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Regulatory Affairs Specialist

vor 2 Monaten

Frankfurt am Main, Hessen, Deutschland Merz Therapeutics Vollzeit
About the Role

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Merz Therapeutics. As a key member of our regulatory affairs department, you will play a critical role in ensuring the compliance of our medicinal products with global regulatory requirements.

Key Responsibilities
  • Develop and implement regulatory strategies to support the approval and maintenance of our medicinal products.
  • Prepare and submit high-quality CMC documentation to regulatory authorities, ensuring compliance with global regulatory requirements.
  • 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 internal stakeholders, and coordinate third-party services.
  • Maintain a detailed understanding of global and national CMC regulatory requirements and best practices.
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.
  • Strong negotiation skills and teamwork.
  • Solution-oriented with a focus on compliance and quality.
What We Offer
  • Individual career development in a purposeful job.
  • Hybrid work model that allows 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.
  • Variety of employer-subsidized benefits, such as WellPass and Germany ticket.