Overview


Job Board | Manager* Regulatory Affairs

Be the ONE who joins a great team.

SCHOTT is an international technology group and a leader in the fields of
special glass and glass ceramics. We value innovation, sustainability and
our pioneering spirit – but above all, we value our employees. Whether in
production or management, you can advance your career and work with highly
qualified colleagues from around the world in an authentic and supportive
environment.

SCHOTT – more than 17,300 experts in 33 countries worldwide – become
one of us! #oneofus
Manager* Regulatory Affairs

Mainz, Germany
Unlimited contract
Hybrid

Because human health matters: Join a team where your visions, your
creativity and our mutual collaboration can make a difference contributing
to something as meaningful as saving lives. At SCHOTT Pharma, we design
solutions to ensure medicines are safe and easy to use for people around
the world. Today, we play an essential role in delivering a COVID-19
vaccine to hospitals and patients.

You perform best in an inclusive environment that is based on mutual trust
and respect among each other. You are a strong communicator – clear,
concise, and persuasive in style always having the best solution for our
products and thus customers in mind. You look for a role with a great deal
of influence in a highly successful company.

Then you might be just the one, we’re looking for.

Be our Manager* Regulatory Affairs for SCHOTT Pharma at our headquarter in
Germany, Mainz.

Your Contribution

As Manager Regulatory Affairs, you are responsible for negotiating
regulatory aspects for product registrations and regulatory issues with
agents and consultants worldwide. Moreover, you coordinate the resulting
measures for product registrations in cooperation with local agents. In
your role,

* You are advisor and trainer for internal BU-P-specific regulatory
topics, such as national product registrations or Drug Master Files
(DMF’s)
* You implement standards and central specifications for the DMF
structure of the BU P locations in consultation, as well as monitor
the DMF’s of the sites and ensure their compliance
* You issue response documents to official enquiries, as well as
statements/LoA’s for product registrations
* You identify and define regulatory requirements for primary packaging
systems and Medical Devices
* You are responsible for the availability and review of required
standards, international pharmacopoeias and guidelines
* You evaluate and provide necessary software tools as well as adjust
processes together with IT to increase efficiency in regulatory
activities
* You support the harmonization of the BU-P quality management system
in the regulatory area
Your Qualifications
* You have a university degree in Science (biotechnology, pharmacy,
pharmaceutical technology), PhD is preferred.
* You have 5-10 years of professional experience in regulatory affairs
/ medical devices with interfaces to quality management.
* It is mandatory that you have profound knowledge of the regulatory
framework for parenteral packaging, combination products and medical
devices.
* Experience of regulatory and medical device business in Asia is
beneficial.
* You are a proactive team player and have already worked with your
structured working methods in international teams.
* You display precise communication skills by abstracting and
explaining complex data in simplified illustrations with your
business fluent English
* language skills; German is a plus.

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

Talent development
International assignments
Holistic corporate health management
Canteen
Please feel free to contact us

We’re looking forward to your application

SCHOTT Pharma AG & Co. KGaA

Mirco Jahn

+496131665196
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*At SCHOTT, it’s your personality that counts – not your gender, your
identity, or origin.


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