Job Description

The Position

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Are you ready to take the next step in your career? Boehringer Ingelheim is seeking a dedicated and experienced Senior Regional Regulatory Lead to join our dynamic team. This role is a critical part of our Regulatory Affairs Excellence Team, where you'll be responsible for a specific therapeutic area(s) and strategic projects/products. You'll contribute to defining and delivering robust regulatory strategies, ensuring timely submissions, approvals, and compliance.


As our expert for regulatory requirements in the region, you'll organize and lead interactions with relevant health authorities, including providing scientific advice during drug development phases, pediatric investigation plans, marketing authorization applications, and life cycle maintenance regulatory activities.


In this role, you'll act as an expert advisor in Regulatory Affairs for critical regional topics. You'll also serve as a mentor within the respective regional RA team for critical projects and activities, both internally and cross-functionally. This is a fantastic opportunity to make a significant impact in a global pharmaceutical company. Join us and help shape the future of healthcare.

Tasks & responsibilities

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As the Senior Regional Regulatory Lead for EUCAN in Human Pharma, you will be crafting robust regulatory strategies for assigned products and/or projects. This includes providing guidance on the development of new compounds for the EUCAN region, pediatric development requirements, and clinical trial applications. You will take the lead in mentoring and guiding junior members or newcomers in the EUCAN team. You will be a supportive figure, deputizing the RRL Team Lead on project-specific topics. With your expertise, you will be responsible for planning, coordinating, and overseeing regulatory submissions required for maintaining marketing authorizations in the EUCAN region. In collaboration with other departments, you will organize, schedule, and lead face-to-face or remote meetings with regulatory authorities in the EUCAN region. As a proactive member of the Regulatory Excellence Team, you will contribute to meetings and other discussions as required, supporting the development of global regulatory strategies. Furthermore, you will act as a liaison and contact partner for RA functions in ROPUs and OPUs in EUCAN, Global RA and other cross-functional stakeholders for the assigned products and/or development projects as well as EMA for products under the EU centralized procedure.

Requirements

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Master's degree or bachelor's degree in either pharmacy or life sciences Extensive, Regulatory Affairs hands-on experience for Human Pharma products in the EUCAN region, with a good understanding of cultural differences and impacts Experience in regulatory support during non-clinical and clinical development of new compounds, pediatric development, and clinical trial applications Deep knowledge in in development, registration, and maintenance of human medicines, including interaction with health authorities; with specific focus in Oncology Experience in other functions outside of Regulatory Affairs and mentoring of other colleagues is highly desirable Excellent negotiation and project management skills paired with willingness to participate in scientific dialogues Critical thinking and self-management abilities as well as professional proficiency in English, both verbal and written communication

Ready to contact us?

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If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or via mail: hr.de@boehringer-ingelheim.com


Step 1: Online application - The job posting is presumably online until 9th January


Step 2: Virtual meeting starting from 12th January


Step 3: On-site interviews start from 26th January