Job Information
Boehringer Ingelheim Regional Regulatory Lead in Ingelheim, Germany
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.
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