**The Position** Step into the dynamic world of pharmaceuticals as a Regional Regulatory Lead for EUCAN in Human Pharma. This pivotal role, nestled within our regulatory affairs excellence team, is the driving force behind our development projects and marketed products. As a Regional Regulatory Lead, you will be the expert voice in regulatory requirements for your region, orchestrating and leading interactions with relevant health authorities. From scientific advice during drug development phases to marketing authorization applications and life cycle maintenance regulatory activities, your expertise will be crucial in delivering robust regulatory strategies for timely submissions, approvals, and compliance. Join us and make a significant impact on the future of healthcare. **Tasks & responsibilities** + As the Regional Regulatory Lead for EUCAN in Human Pharma you will provide a robust regulatory strategy for assigned products and/or projects, including guidance on maintenance & development needs in the Region EUCAN, pediatric development requirements and clinical trial applications. + You will plan, coordinate, and oversee regulatory submissions required for maintenance of marketing authorizations in the EUCAN region. + In collaboration with other related departments, you will organize, schedule, and carry out official in-person and remote meetings with regulatory authorities in EUCAN countries. + You will contribute as an active member to the Regulatory Excellence Team meetings and other meetings as required, to support development of worldwide regulatory strategies. + Moreover, you will act as an interface & contact partner for: + RA functions in ROPUs and OPUs in EUCAN + Global RA and other cross-functional stakeholders for the assigned marketed products and / or development projects + EMA for products under the EU centralized procedure **Requirements** + Master’s or bachelor’s degree in either pharmacy or life sciences + Several years of pharmaceutical industry experience in Regulatory Affairs in Human Pharma; any experience in other functions outside of RA would be highly desirable + Regulatory affairs "hands on" experience in the region with an understanding for different cultures and their impact + Practical experience in handling new developments, registrations, and maintenance of registered products + Outstanding ability in both negotiating and managing projects paired with knowledge of how to interact with health authorities + Capability and readiness to apply scientific expertise and participate in informed scientific dialogues + A critical thinker who has the aptitude to self-manage their workload, which includes the ability to reorganize priorities and meet tight deadlines + Proficiency in English communication, both verbal and written **Ready to contact us?** If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or per mail: hr.de@boehringer-ingelheim.com Recruitment process: Step 1: Online application - application deadline is beginning of January 2025 Step 2: Virtual meeting in the period from beginning till mid of January 2025 Step 3: On-site interviews beginning end of January 2025 All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.