Capability Lead Ra Regions

vor 6 Monaten

Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

**The Position**:
Welcome to a dynamic and global role that sits at the heart of Regulatory Affairs (RA). Reporting directly to a Team Lead for Regulatory Excellence, this position offers a unique opportunity to lead and shape the future of our regulatory processes and technologies.

You will lead a Capability Area or a standalone Project, you will be instrumental in translating the capability strategy into an actionable plan. Your expertise will be crucial in prioritizing tasks, rolling out deliverables, and providing oversight.

As a Capability Lead, you will also be the driving force behind your team, fostering collaboration and managing relationships with end users, cross-functional stakeholders, and vendors in a matrix environment.

Join us in this exciting role and contribute to our mission of shaping a fit for future Regulatory Affairs Organization and ensuring global regulatory compliance.

**Tasks & responsibilities**:

- You will be entrusted with the design, development, implementation, and maintenance of processes and technologies that enable the Regulatory Affairs Organization to efficiently plan and deliver on our regulatory strategy. Your commitment to continuous improvement will ensure high quality and regulatory compliance on a global scale.
- In addition, you will also serve as the Global Process Owner (GPO) for assigned processes. You will ensure the impact-evaluation of new or draft guidelines and implement/adapt our processes and global standards according to these needs.
- Your role will involve coaching, directing, and overseeing team members. You will guide them to design, develop, and implement quality projects within the stipulated timeline and budget. You will also monitor the performance of established processes and initiate process improvements as necessary.
- You will shape the vision and strategy of the Capability/Project by creating and maintaining a capability roadmap. This roadmap should anticipate the demands of the pipeline and the changing regulatory environment. You will always keep regulatory excellence and compliance as your top priorities.
- Lastly, you will steer strategic external partnerships and engagements that form part of a global process environment. This includes system implementation for regulatory strategy, execution, and compliance both in the EU and worldwide.

**Requirements**:

- Bring your wealth of experience in Regulatory Affairs, business/process consulting, project management, external relationship management, business architecture management, and/or GCP systems implementation to the table. Experience in a global setting will set you apart.
- Your comprehensive knowledge across the healthcare/pharmaceutical industry, digital/IT industry, and/or Regulatory Affairs will be a key asset.
- Showcase your proven expertise in process design/management, process consulting, organizational change management, and project management. Experience in various local and global roles is a plus.
- Your exceptional interpersonal skills will be put to good use, as you positively influence others, persuading or convincing them to gain their support.
- We value a customer-oriented mindset. Your ability to actively engage with customers, build strong customer relationships, and deliver customer-centric solutions will be highly appreciated.
- Impress us with your excellent public speaking skills and your ability to deliver compelling presentations to large audiences. Proficiency in written and spoken English is a must.

**Ready to contact us?**:
Recruitment process:
Step 2: Virtual meeting in the period from beginning end of May

Step 3: On-site interviews beginning the first half of June

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