Job Information
Boehringer Ingelheim Regional Regulatory Lead in Ingelheim, Germany
The Position
The Regional Regulatory Lead is an integral member of the regulatory affairs excellence team, responsible for the assigned development projects and marketed products and contributes to the delivery of robust regulatory strategies to enable timely submissions, approvals, and compliance.
Tasks & responsibilities
As the Regional Regulatory Lead for Emerging Markets you will provide a robust regulatory strategy for assigned products and/or projects, including guidance on maintenance & development needs in the Region Emerging Markets, pediatric development requirements and clinical trial applications.
You will plan, coordinate, and oversee regulatory submissions required for maintenance of marketing authorizations in the Emerging Markets region.
In collaboration with other related departments, you will organize, schedule, and carry out official in-person and remote meetings with regulatory authorities in Emerging Markets 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:
Regulatory Affairs functions in ROPUs and OPUs in Emerging Markets.
Global Regulatory Affairs and other cross-functional stakeholders for the assigned marketed products and / or development projects.
Requirements
Master’s or bachelor’s degree in either pharmacy or life sciences.
Several years pharmaceutical industry experience in Regulatory Affairs and any experience in other functions outside of Regulatory Affairs would be highly desirable.
Regulatory affairs "hands on" experience in the region and understands different cultures and their impact.
Experience in development, registration, and maintenance of human medicine, including interaction with health authorities.
Demonstrated understanding of the regulatory process and technical competence in core areas of drug development
Capability and willingness to participate in scientific dialogues.
Excellent collaboration, communication, and negotiation skills.
Proficiency in English communication, both verbal and written, 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 10th of July, 2024
Step 2: Virtual meeting in the period from mid of July
Step 3: On-site interviews beginning of end of July
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.