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Head Regulatory Information Management (m/f/d)

Grünenthal -
Aachen

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Details zur Stelle

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Head Regulatory Information Management (m/f/d)

Country: Germany

City: Aachen

Department: Research & Development

Job ID: 45008

Professional | Permanent | Full-time | Hybrid

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 life 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:

Delivering high-quality regulatory information management services for Grünenthal, including:
Leading the evolution and prioritization of the GRA digital roadmap in close alignment with R&D Digital Transformation Office and IT
Driving the development of Regulatory Data Management & Governance capabilities aligned with R&D data strategy & governance
Enabling regulatory data analytics capabilities to maximize data value
Leading integration of RIMS with cross-functional systems and manages complex data landscapes
Defining and executing Grünenthal’s regulatory data strategy to ensure compliance with evolving global regulations (e.g. IDMP, ESMP, eCTD 4.0)
Leading vendor selection, performance management, and external partnerships for GRA digital solutions and operations
Driving operational efficiency, resource optimization, and budget management for RIM services
Monitoring digital regulatory trends to ensure global readiness for upcoming requirements
Representing Grünenthal in external industry forums and engages external experts as needed

What you'll bring to the table

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

University degree in science, technology, or equivalent experience
10+ years of experience in regulatory information management within the pharmaceutical industry
Strong knowledge of RIM processes across development and marketed products (EU & US required; LATAM a plus)
In-depth understanding of relevant regulatory standards and regulations (e.g. IDMP, xEVMPD, eCTD, ESMP)
5+ years of hands-on experience with Veeva Vault RIMS and its business processes
Experience with multiple RIM technologies and digital trends in Global Regulatory Affairs
Global regulatory experience with a focus on EU and US
Proven leadership and people development experience, driving high-performing teams
Solid experience in budget, vendor, and contract management
Strong project, people, change, and stakeholder management skills
Excellent communication, negotiation, and presentation skills
Strategic mindset with the ability to translate long-term vision into actionable goals
Ability to work effectively in a matrix organization
Excellent business English skills

______________________________________

"At this moment, we are in an exciting time of change, modernizing our RIM landscape. Join us to become part of the adventure!"

Silke Thömmes, the Hiring Manager

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 28 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2024, Grünenthal employed around 4,300 people and achieved sales of € 1.8 billion.

Your HR contact:

Angelika Will

Jetzt bewerben

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