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Regulatory Affairs Project Manager (f/m/d)

Country:  Germany
City:  Aachen
Department:  Research & Development
Job ID:  39599

 

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 one or more Global Regulatory Strategist (GRS) in the development and implementation of the global regulatory strategy - for defined, delegated (sub)projects to take on the role of a Global Regulatory Strategist (GRS)
  • Delivering smart tactical plans to properly execute agreed regulatory strategies in collaboration with the regulatory subteam. 
  • Adhering to standardized processes and workflows to safeguard regulatory compliance and seamless collaboration across interfaces. 
  • As member of the regulatory subteam, ensuring that tasks get prioritized with focus on criticality for business.
  • Being responsible to liaise with the relevant functional experts and participate in cross-functional teams as agreed in regulatory subteam.
  • Serving as business partner for strategies for CoGs optimization and drives creation and updates of product information 
  • Monitoring changes in regulatory guidelines and competitive landscape in the relevant territories and analyses and shared potential impact these changes may have on the product development program/life cycle and the regulatory submission/procedure management.
  • Supporting due diligence activities.

 

What you'll bring to the table
To make the most of this role and truly thrive, you should have:

  • Scientific university degree (Master or PhD)  or equivalent in life science (pharmacy, biology, chemistry or related discipline) 
  • Profound years of experience in the pharmaceutical industry or health authority
  • Regulatory experience in a global setting, main territorial focus: European Union/US and Latin America, Experience in APAC beneficial
  • In-depth knowledge of relevant ICH/EU/US guidelines and regulations covering all aspects of regulatory submission and procedure management
  • Sound understanding of relevant scientific
  • Excellent English communication skills, both written and verbal, German and Spanish beneficial
  • Strong project management, negotiation and leadership skills
  • Flexible, pragmatic, solution-oriented, independent and proactive working style
  • Ability to link long ranging visions/concepts to one’s daily work and to lead, coordinate and synchronize multiple projects, overcome obstacles and be flexible in changing daily workload priorities

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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