Head of Regulatory Affairs Systems Business Support

vor 1 Woche

Frankfurt Am Main, Deutschland BI Vetmedica GmbH Vollzeit

**THE POSITION**:
In our Boehringer Ingelheim Animal Health Business Unit (BI AH), the Regulatory Affairs & Pharmacovigilance team within Global Innovation enhances business value along the complete life-cycle of veterinary medicines. This starts with research and product development, continues with quality and timely regulatory submissions and approvals in our global target markets and comprises maintenance of our product portfolio on the market for many years, in line with applicable rules and regulations.

Our vision for the future foresees an IT environment that connects and integrates the organization with key BI-internal systems and beyond BI to drive automation and efficiency.

**Tasks & responsibilities**:
- You will lead and develop a global team providing services for global, GxP-relevant and cross-functionally used Animal Health Regulatory Affairs (RA) systems according to the strategic vision and goals for the function including internal and external resources and budget planning.- In addition, you will provide strategic direction for governing and enhancing existing systems and for designing the future, state-of-the-art interconnected Animal Health Regulatory Affairs Pharmacovigilance (RAPV) system landscape.- Furthermore, you will develop, design and convey an inspiring vision of the strategic Animal Health Regulatory Affairs Systems Roadmap and communicate properly within the company to stakeholders at all levels.- With the support of your team, you will provide operational services for the AH RAPV systems and ensure that systems and business support services are compliant with internal and external regulations.- Also, you will oversee the portfolio of global initiatives and innovative projects lead, defined and managed by team members.- You will represent Animal Health Regulatory Affairs in multi-functional meetings with internal and external stakeholders, including Health Authorities.

**Requirements**:
- Master in Biology, Chemistry, Engineering, Mathematics or Computer Science- Long term work experience such as in IT or other business areas, including business consultancy and project management-
- Computer System Validation (e.g. LeVa, GAMP5) principles- Strong leadership skills in order to lead a global team (line management and matrix organizations) and to manage stakeholders across and outside the organization- Effective communicator with excellent negotiation and interpersonal skills and the ability to form productive working relationships at all levels across disciplines and nationalities. Strong customer focus.- Strong team player, able to drive change. Advocates for innovative new technologies, solutions, and process-driven approaches in a complex business environment.- Excellent verbal and written communication skills in English. German or French is of advantage.

**Ready to contact us?**:
Please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330.

Recruitment process:
Step 2: Virtual meeting in the calendar week 37

Step 3: On-site interviews beginning of calendar week 38

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