Manager Regulatory Affairs (m/f/d)* (Sofort einstellen)
SCHOTT AG Mainz Vollzeit
About us
Human health matters. That is why SCHOTT Pharma develops scientifically soundsolutions that ensure medications are safe and easy to use for people around
the world. Over 4,600 people from more than 60 nations work at SCHOTT Pharma
every day to contribute to global health care. With 16 state-of-the-art plants
in Europe, North and South America, and Asia, the company is represented in
all major pharmaceutical markets. SCHOTT Pharma AG & Co. KGaA is located in
Mainz and listed on the MDAX of the Frankfurt Stock Exchange. It is part of
SCHOTT AG, a company of the Carl Zeiss Foundation. In this sense, SCHOTT
Pharma is committed to sustainability for society and the environment and has
committed to becoming climate neutral by 2030.
## Your Contribution- 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
## Your Benefits
SCHOTT’s openness to promote your further development is just as great as ouradditional 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.
- Subsidized pension plan; Exclusive employee benefitsdiscounts; Flexible
- working hours; Talent development
- ## 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
- At SCHOTT, it’s your personality that counts – not your gender, your identity, or origin
SCHOTT AGWiesbaden, 9 km von Mainz
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...
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