Regulatory Affairs Manager

Vor 6 Tagen

Bingen am Rhein, Rheinland-Pfalz, Deutschland SCHOTT AG Vollzeit
About SCHOTT Pharma

SCHOTT Pharma is a leading developer of scientifically sound solutions for the pharmaceutical industry. Our mission is to ensure the safety and efficacy of medications worldwide. With a global presence and a team of over 4,600 experts from more than 60 nations, we strive to make a positive impact on global healthcare.

Key Responsibilities
  • Manage regulatory aspects for product registrations and collaborate with agents and consultants to address global regulatory issues.
  • Lead interdisciplinary teams to establish new processes and enhance regulatory contributions to the business.
  • Serve as a subject matter expert and trainer for internal regulatory topics, including National Product Registrations and Drug Master Files (DMFs).
  • Develop and implement standards and central specifications for dossier structures across global markets for our customers.
  • Ensure product-dossier compliance across our various sites for global registration procedures of our customers.
  • Prepare response documents for official inquiries and provide statements for product registrations.
  • Identify and define regulatory requirements for primary packaging systems and Medical Devices.
  • Ensure we have the necessary standards, international pharmacopoeias, and guidelines at our fingertips.
  • Evaluate and implement software tools in collaboration with IT to streamline regulatory processes.
Requirements
  • A university degree in Science (biotechnology, pharmacy, pharmaceutical technology) is required, with a PhD preferred.
  • 5-10 years of professional experience in regulatory affairs or medical devices, with a focus on interfaces with quality management.
  • Profound knowledge of the regulatory framework for parenteral packaging, combination products, and medical devices is essential.
  • Proven skills in project management and ability to think interdisciplinary.
  • Strong ability to act as a team player.
Benefits

SCHOTT Pharma offers a unique corporate culture that emphasizes equity, diversity, and inclusion. We provide a range of benefits, including active health management, flexible working hours, and corporate pension plans. Our goal is to support the development of our employees and create a positive work environment.

We are committed to sustainability and have set a goal to become climate neutral by 2030. Our company is part of SCHOTT AG, a leading international technology group.

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