RIM Business Project Management Lead (m/f/d)

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:

• Acting as Project Lead for the implementation of Grünenthal’s new Regulatory Information Management (RIM) Platform, and for the continuous evolution of the platform
• Leading the RIMS Implementation Project Plan, working closely with & overseeing the project workstreams to ensure project deliverables are met
• Providing RIMS subject matter expertise, driving coordination between project workstreams, alignment between stakeholder groups, vendors & partners
• Ensuring that internal cross functional teams (Business functions & IT) & external teams (Product & Implementation) are collaborating appropriately to deliver a comprehensive data migration strategy & data catalogue to support the implementation & management of the new RIMS platform
• Leading the Project Operational Governance & reporting, tracking progress, proactively highlighting risks and mitigation actions, tracking decisions
• Supporting & facilitating the project communication strategy and change management approach
• Ensuring that implementation partners & vendors are fully onboarded to the project, and have clear understanding of the project plan, scope, deliverables & timelines.

What you’ll bring to the table

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

• Bachelor's degree required in science, engineering, or related field (advanced degree preferred)
• At least 7-10 years of experience working in Regulatory Affairs in the pharmaceutical industry, at a vendor or at a health authority (main territorial focus: European Union/US)
• Prior experience in managing and/or supporting implementation of Regulatory Information Management Systems or platforms
• Good understanding & experience with RIM Functional Processes – Registrations Management, Submission Planning, Submission Content Planning, Document Management, Publishing, HAQ, Labeling
• Understanding of ISO IDMP Standards, SPOR, PLM, EU IG
• Good understanding of Regulatory business process & requirements (Marketing Authorization, Renewals, Variations, Labeling, etc.) – EU & US
• Excellent English communication skills
• Strong team player with an open, flexible and adaptable personality

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