About us

Our Business Unit Pharmaceutical Systems is one of the world’s leading manufacturers of drug containment solutions and delivery systems for injectable drugs. More than 600 production lines in 14 countries worldwide produce more than 10 billion syringes, vials, ampoules, cartridges and special articles of tubing glass or polymer.

Your Contribution

• Lead the charge in managing regulatory aspects for product registrations and tackling global regulatory issues with agents and consultants.
• Establish and maintain a Regulatory Service Concept together with supporting disciplines which bundles the regulatory content and deliverables towards our customers
• Lead and coordinate interdisciplinary teams to establish new processes and services to improve our regulatory contribution to our business
• Collaborate closely with local agents and Competent Authorities to coordinate and execute measures for product registrations.
• 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.
•  Keep a keen eye on product-dossier compliance across our various sites for global registration procedures of our customers.
•  Craft polished response documents for official inquiries and furnish statements for product registrations.
• Pinpoint 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, working hand in hand with IT to streamline regulatory processes.
• Play a pivotal role in harmonizing the quality management system in the regulatory realm.

Your Profile

• A university degree in Science (biotechnology, pharmacy, pharmaceutical technology) is required, and a PhD is preferred
• You should possess 5-10 years of professional experience in regulatory affairs or medical devices, with a focus on interfaces with quality management.
• Proven skills in project management and ability to think interdisciplinary.
• Profound knowledge of the regulatory framework for parenteral packaging, combination products, and medical devices is essential.

Your Benefits

SCHOTT’s 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. Discover a special corporate culture where everyone has the opportunity to develop their entire potential.

At SCHOTT, you can expect a unique corporate culture where we emphasize equity, diversity, and inclusion. We know: motivated and committed employees are the precondition for the success of our company.

Flexible working hours; Further training and education; Multiple career opportunities; Trust-based working time

Please feel free to contact us

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, please send us your application: SCHOTT Pharma AG & Co. KGaA, Human Resources, Andrea Kusemann

*At SCHOTT, it’s your personality that counts – not your gender, your identity, or origin.