Regulatory Affairs Manager
vor 3 Wochen
SCHOTT is a leading global pharmaceutical company that develops scientifically sound solutions to ensure medications are safe and easy to use for people worldwide. With over 4,600 employees from more than 60 nations, SCHOTT Pharma is represented in all major pharmaceutical markets through 16 state-of-the-art plants in Europe, North and South America, and Asia.
Your RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for managing regulatory aspects for product registrations and tackling global regulatory issues with agents and consultants. You will lead interdisciplinary teams to establish new processes, enhancing regulatory contributions to the business.
Key Responsibilities- Manage regulatory aspects for product registrations and tackle global regulatory issues with agents and consultants
- Lead interdisciplinary teams to establish new processes, enhancing regulatory contributions to the business
- Serve as the go-to advisor and trainer for internal SCHOTT-Pharma-specific regulatory topics, such as National Product Registrations and Drug Master Files (DMFs)
- Roll out and oversee 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
- Play a key role in harmonizing the quality management system in the regulatory realm
- A university degree in Science (biotechnology, pharmacy, pharmaceutical technology) is required, PhD is 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
SCHOTT offers a unique corporate culture where everyone has the opportunity to develop their entire potential. We emphasize equity, diversity, and inclusion, and we know that motivated and committed employees are the precondition for the success of our company. Our benefits include subsidized pension plans, exclusive employee benefits/discounts, flexible working hours, and talent development opportunities.
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