Key Facts

Remote From:

Full time

English, German

Hard Skills

Lifecycle Management Regulatory Compliance Regulatory Compliance Medical Writing Regulatory Compliance Regulatory Compliance Specimen Labeling Project Management Digital File Management Technical Writing +1 more

Other Skills

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Procedure Development
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Cooperation
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Adaptability
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Communication
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Teamwork
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Detail Oriented
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Intellectual Curiosity

Roles & Responsibilities

Academic degree in pharmacy or a related scientific field
Strong communication skills with fluency in English and German (oral and written)
Strong project management skills
Excellent team player with attention to detail

Requirements:

Contribute to MAA strategy, lifecycle management, and local regulatory activities (e.g., technical/medical writing, labeling, submissions and procedure management)
Manage regulatory submissions, including eCTD publishing
Lead global and European regulatory projects and provide guidance on EU and international procedures and guidelines
Provide German-language regulatory support to international customers in the German market

Job description

GENERAL INFORMATION

We are looking for a
REGULATORY AFFAIRS MANAGER (m/f/x)
Location: Heidenheim/Berlin/Porto/Riga or remote
Starting: at the next possible date

You don’t always swim with the tide:
In a growing company, we are looking for people who don’t feel like a fish out of water in new situations and with new customers.
You are curious to explore your regulatory knowledge on different product types? Or you would like to implement best practice in your daily work and strive against the stream sometimes rather than „doing it as it has always been done“? Come join us at THE FORCE!

YOUR PROFILE

How you’ll hook us:

An academic degree in pharmacy or related scientific field prevents you from being in deep waters.
Your strong communication skills as well as your oral and written proficiency in English and German won’t let you drown when it comes to working with co-workers and customers alike.
Your strong project management skills help everyone to get their head out of water.
As an excellent team worker, cooperation is nothing you have to flounder through.
Instead of having scales on your eyes, an eye for detail completes your skills.

YOUR TASKS

There are plenty of fish in the sea, but you might be the one we’re looking for if…

…you are in the swim in at least one area of our widely span activities from MAA strategy to life-cycle measures or local regulatory activities, e.g. technical or medical writing, life-cycle management, submission and procedure management, labelling.
…your experience allows you to handle regulatory submissions (including eCTD publishing) swimmingly.
…global and/or European projects aren’t unchartered waters to you.
…you bring along an ocean of knowledge when it comes to regulatory procedures and guidelines in the EU and beyond.
…your business fluency in German enables you to provide our international customers with the best possible support in the German market.

Ready for a sea change?
All of this sounds exactly like the new challenge you’ve been fishing around for? Test the waters and send your application to Dr. Andrea Schüssele via our application form.

Ready to apply?

APPLY

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