Regulatory Affairs Manager
vor 3 Wochen
About SCHOTT
We are a leading international technology group in the areas of specialty glass, medical and optoelectronic components. Our innovative solutions improve the quality of life for millions of people and help to save lives. We are committed to sustainability and have set ambitious targets to reduce our environmental impact.
Your Role
- Develop and implement regulatory strategies to ensure compliance with global regulations and standards
- Lead cross-functional teams to establish new processes and enhance regulatory contributions to the business
- Provide expert advice and training on regulatory topics, including national product registrations and drug master files
- Roll out and oversee standards and central specifications for dossier structures across global markets
- Ensure product dossier compliance across various sites for global registration procedures
- 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 to streamline regulatory processes
- Play a key role in harmonizing the quality management system in the regulatory realm
Your Profile
- 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
Your Benefits
We offer a unique corporate culture that emphasizes equity, diversity, and inclusion. Our employees are motivated and committed to our company's success. We provide a range of benefits, including subsidized pension plans, exclusive employee discounts, flexible working hours, and talent development opportunities.
Please Contact Us
We are an equal opportunities employer and welcome applications from diverse candidates. If you are interested in this role, please submit your application through our website.
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