Head CMC Compliance R&D and Projects (m/f/d)

Our people in Manufacturing & Global Operations share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal’s future.

What the job looks like

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

• Designing regulatory CMC strategy in cooperation with stakeholders and aligned with overall R&D project plan
• Conception of planning and interdepartmental coordination of work packages for major submission for gaining MAs as well as Clinical trials for CMC topics in time and quality
• Responsible for execution of R&D projects wrt designing CMC strategies and providing guidance to ensure regulatory compliance in time and quality
• Set up, review and establish appropriate efficient processes for management of R&D projects in GQA CMC in cooperation with stakeholders
• Supervising GQA CMC projects to ensure execution according to current standards and in time and quality to ensure safe and reliable products for our patients
• Supervising team member dealing with R&D projects to ensure regulatory compliance in time and quality
• Responsible for setting up and coordinating appropriate and timely preparation, review and maintenance of CMC sections of IMPDs/INDs and other regulatory filings to fit with overall project plan
• Providing guidance for operational CMC regulatory support with overall responsibility for the regulatory compliance of supervised R&D projects including management of changes

What you´ll bring to the table

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

• Preferably Pharmacist or comparable degree in natural science
• Sound experience (at least 5 years) in CMC R&D Regulatory as well as in GMP environment
• Leadership experience of virtual teams where people can unleash their potential and strong team player 
• Knowledge of relevant national and internal guidelines and regulatory requirements for e.g. EU, US, LatAm, JPN
• English fluent
• Passionate about GRT’s purpose of improving patients’ lives, global and service-oriented mind-set as well as strong sense of cultural/diverse backgrounds
• Entrepreneurial thinking and looking for solutions – driving realization combined with capable working under tight and shifting conditions
• Thinking and acting strategically, creating opportunities for growth and challenge the status quo, try new things & take smart risks

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"In Grünenthal you count and you can make an impact. In this position you are working together with colleagues from many functions on various topics: The atmosphere, team spirit and achievements are remarkable. 
We focus on the patient and developing and marketing safe and reliable medicinal products: Safety first - Quality always."

Scheier Alexandra, the Hiring Manager