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 development of new compounds for 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 departments, you will organize, schedule, and lead a F2F or remote meetings with regulatory authorities in the EUCAN region.

• You will proactively contribute as a strategic member to the Regulatory Excellence Team meetings and other meetings as required, to support development of global 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 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 pharmaceutical industry experience in Regulatory Affairs in the Human Pharma

• Experience in other functions outside of RA would be highly desirable

• Experiences in regulatory support during non-clinical and clinical development of new compounds for the Region EUCAN, pediatric development and clinical trial applications.

• Regulatory affairs "hands on" experience in the region and understanding of different cultures and their impact

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

• Excellent negotiation and project management skills

• Capability and willingness to participate in scientific dialogues

• A critical thinker with ability for self-management

• Professional proficiency in English, both verbal and written communication, is required

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 3rd of June, 2024

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

Step 3: 2nd virtual interviews beginning end of June, 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.