Regulatory Affairs Specialist
vor 2 Wochen
About SCHOTT Pharma
We are a leading developer of scientifically sound solutions for the pharmaceutical industry, ensuring medications are safe and easy to use worldwide. Our team of over 4,600 professionals from more than 60 nations works together to contribute to global healthcare. With 16 state-of-the-art plants in Europe, North and South America, and Asia, we are represented in all major pharmaceutical markets. Our company is committed to sustainability for society and the environment, aiming to become climate neutral by 2030.
Your Role
- Manage regulatory aspects for product registrations and collaborate with agents and consultants to address global regulatory issues.
- 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).
- Develop 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.
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 where everyone has the opportunity to develop their entire potential. Our openness to promote your further development is just as great as our additional benefits. Ranging from active health management via flexible working hours and hybrid work all the way to corporate pension plans: everything geared to suit your goals and needs.
At SCHOTT, you can expect a special corporate culture where we emphasize equity, diversity, and inclusion. We know: motivated and committed employees are the precondition for the success of our company.
Subsidized pension plan; Exclusive employee benefits/discounts; Flexible working hours; Talent development
Join Our Team
You can expect interesting tasks and challenging projects, as well as motivated and friendly teams in fields that influence our future. Do you want to be successful with us? Then, apply now and become a part of our team.
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