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Regional Regulatory Specialist
vor 4 Monaten
**The Position**:
Are you passionate about the pharmaceutical industry and eager to make a significant impact? We are seeking a dedicated and innovative Regional Regulatory Specialist to join our team. In this role, you will have the opportunity to leverage cutting-edge technology to coordinate and streamline the processing of crucial regulatory documents. You will be instrumental in developing innovative concepts for acquiring regulatory approvals and digitizing and optimizing these processes. As a key interface across various teams, you will drive digital transformation in regulatory affairs, significantly impacting product and project-related activities. If you are looking for a challenging role that offers the chance to shape the future of regulatory affairs, we would love to hear from you.
***Tasks & responsibilities**:
- Coordinate and process crucial documents for Marketing Authorization Applications, post-approval changes, and renewals, leveraging regional regulatory expertise.
- Consolidate feedback on legalization requirements, considering cost and lead time aspects, and develop an efficient signatory process.
- Develop and provide concepts for acquiring Certificate of Pharmaceutical Products (CPP), registration samples, and legalization and notarization concepts, in collaboration with global and local stakeholders.
- Support the Regional Regulatory Leads with in-depth regional regulatory knowledge, including detailed regional plans for CPPs, registration samples, and legalization and notarization topics.
- Act as an interface and contact partner for regulatory affairs functions across various teams, supporting product and project related regulatory activities.
***Requirements**:
- Bachelor's degree, preferably in life sciences, or equivalent professional experience
- Some experience in Regulatory Affairs or related disciplines in the pharma industry
- A general understanding of regulatory requirements, in-depth knowledge of regional regulatory requirements and implications for CPPs would be beneficial
- Team player who can effectively manage multiple tasks and meet tight deadlines
- Excellent communication skills, with fluency in both English and German, are a prerequisite - the role involves international exposure, hence an understanding and appreciation of different cultures is essential
***Ready to contact us?**:
Recruitment process:
Step 2: Virtual meeting in the period from mid of June, 2024
Step 3: On-site interviews beginning of beginning of July, 2024
