Regional Regulatory Lead
vor 3 Wochen
**Tasks & responsibilities**:
- You will plan, coordinate, and oversee regulatory submissions required for maintenance of marketing authorizations in the EUCAN region.
- In collaboration with other related departments, you will organize, schedule, and carry out official in-person and remote meetings with regulatory authorities in EUCAN 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:
- RA functions in ROPUs and OPUs in EUCAN
- Global RA and other cross-functional stakeholders for the assigned marketed 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 and any experience in other functions outside of RA would be highly desirable
- Regulatory affairs "hands on" experience in the region and understands different cultures and their impact
- Practical experience in handling new developments, registrations, and maintenance of products, particularly in cardiometabolic area
- Having knowledge of how to interact with health authorities and sensitivity to diverse cultural backgrounds and their effects
- Outstanding abilities in both negotiating and managing projects
- A critical thinker who has the aptitude to self-manage their workload, which includes the ability to reorganize priorities and meet tight deadlines
- 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,
Recruitment process:
Step 2: Virtual meeting in end of March, 2024
Step 3: 2nd virtual interviews mid of April, 2024
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