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The Position

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. Reporting directly to the Head of RA Region EUCAN, 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

• 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 Region EUCAN, 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.

• 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

• EMA for products under the EU centralized procedure.

Requirements

• Master degree or bachelor degree in either pharmacy or life sciences

• Extensive experience in Regulatory Affairs within the pharmaceutical industry combined with hands-on experience in Regulatory Affairs in the EUCAN region, with an understanding of cultural impacts

• Experience in other functions outside of Regulatory Affairs is highly desirable

• Familiarity with CRM is appreciated

• Experience in regulatory support during non-clinical and clinical development of new compounds, pediatric development, and clinical trial applications

• Knowledge in in development, registration, and maintenance of human medicine, including interaction with health authorities

• Excellent negotiation and project management skills

• Willingness to participate in scientific dialogues

• Critical thinking and self-management abilities

• Professional proficiency in English, both verbal and written communication

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 7th of August, 2024

Step 2: Virtual meeting in the period from mid of August, 2024

Step 3: On-site interviews beginning of end of August 2024

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.