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Manager Regulatory Affairs, Drug Safety & Compliance Liaison (all, 100%)

Country:  Austria
City:  Brunn am Gebirge
Department:  Research & Development
Job ID:  43478

 

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

 

What the job looks like
o    Ensure local regulatory approval and maintenance of product licenses. 
o    Support and ensure timely submission of applications for CTAs, MAs, variations and renewals. 
o    Ensure maintenance of product information texts and the review of regulatory aspects of company product related materials. 
o    Maintain overview of the registration status for all products in Austria, including tracking of all submissions and commitments.
o    Operational support to Drug Safety DACH Team in e.g. ICSR identification, Regulatory Intelligence monitoring, implementing risk minimization measures
o    Maintain and monitor compliance infrastructure within the company to ensure compliance with local pharmaceutical industry practices, Pharmig Code and GRT Code of Conduct. 
o    Plan and conduct compliance trainings. 
o    Active participation in compliance audits and inspections.    

 

What you'll bring to the table

o    University degree in economics or sciences and/or advanced degree in health or life sciences.
o    Work experience in regulatory affairs and drug safety within the pharmaceutical industry.
o    Thorough knowledge of regulatory and drug safety processes and relevant Regulations (EU legislations and guidelines, local law etc).
o    Preferably knowledge in NeeS/eCTD publishing software (e.g.DocuBridge).
o    Very structured and attention-to-detail working style.
o    Strong communication, negotiation and problem solving skills.
o    Ability to work flexible, proactive, open, adaptable to environment and supportive of training.
o    Strategic thinking, commercial awareness and ability to work in a global matrix environment.
o    Fluent business English language skills.

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About Grünenthal

Grünenthal is a global leader in pain management and related diseases. As a science-based, fully-integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focusing all of our activities and efforts on working towards our vision of a world free of pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America and the US. Our products are available in approx. 100 countries. In 2022, Grünenthal employed around 4,400 people and achieved revenues of € 1.7 bn.

Your HR contact: 
Katrin Notz

+41 55 647 31 22 
Katrin.Notz@grunenthal.com
 

Meet our teams
Website: careers.grunenthal.com
LinkedIn: Grunenthal Group
Instagram: @grunenthal

Meet our teams
Website:
careers.grunenthal.com
LinkedIn:
Grunenthal Group
Instagram:
@grunenthal

Apply now »