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Regulatory Compliance & Excellence Lead / Vendor Management (m/f/d)

Country:  Germany
City:  Aachen
Department:  Research & Development
Job ID:  39163

 

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

Each day you'll enjoy a variety of challenges, such as:

  • Supporting definition and drive execution of outsourcing strategies (e.g. new collaboration models with clinical vendors, outsourcing of Regulatory Affairs work packages)
  • Managing the compliance of relevant regulatory vendors using defined performance indicators that measure adherence to relevant processes and predefined targets/standards
  • Training and coaching regulatory functions involved in cooperation with a vendor
  • Driving successful delivery of initiatives to further strengthen compliance ensuring regulatory excellence and a practical/business driven approach
  • Supporting activities related to the label management process as necessary
  • Supporting design and implementation of an overall regulatory compliance strategy and ensure adherence
  • Serving as interface for GxP-audits/inspection, you plan and perform compliance testing (incl. internal audits) to Global Regulatory Affairs processes, including liaising with external auditors, recommending changes where necessary
  • Being able to tap into external expertise where necessary in an agile manner and to benchmark Grünenthal’s vendor management through a network of external advisors and experts


What you'll bring to the table

To make the most of this role and truly thrive, you should have:

  • University degree (Master or PhD) or equivalent in Life Science (pharmacy, biology, chemistry or related discipline)
  • Experience in the pharmaceutical industry
  • Broad working experience in Regulatory Affairs within pharmaceutical industry or at a health authority; with a track record in clinical trial management and collaboration with external vendors
  • Experience in Quality Management Systems
  • Excellent English communication skills, both written and verbal (German and Spanish are beneficial)
  • Strong project management and stakeholder management skills
  • Being able to lead, coordinate and synchronize multiple projects, overcome obstacles and be flexible in changing daily workload priorities
  • A structured, yet pragmatic and solution-oriented working style

 

 

About Grünenthal

Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned 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 focussing 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 29 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2020, Grünenthal employed around 4,500 people and achieved sales of € 1.3 bn.

Your HR contact: 
Angelika Will

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

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