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Regulatory Affairs Project Manager

Country:  Portugal
City:  Lisbon
Department:  Drug Safety & Regulatory Affairs
Job ID:  38235

 

Our Corporate Functions teams make sure everything at Grünenthal runs smoothly by bringing together people with a wide range of skills – from experts in finance, IT, HR, law and compliance through to business strategists and creative media minds. If you’re a great collaborator and a strong communicator, you’ll feel right at home here. Join our team and join forces with colleagues across our business to maximise our company’s positive impact on patients and their families.

 

What the job looks like:

 

  • Supporting one or more Global Regulatory Strategist (GRS) in the development and implementation of the global regulatory strategy;
  • 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.

 

What you'll bring to the table:

 

  • 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.

 

 

 

 

Come and join our team!  

 

 

 

 

 

 

 

 

More information: careers.grunenthal.com

 

Follow us on:
LinkedIn: Grünenthal GBS
Instagram: Grünenthal GBS 

 

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:
Fabiana Guerra

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

Apply for Job