Regional Regulatory Lead

vor 3 Wochen


Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

**Tasks & responsibilities**:

- 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
- 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,

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

Step 3: 2nd virtual interviews beginning end of June, 2024



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