Celltrion Healthcare Deutschland GmbH
Department:
QM/SCM
Location:
Office-based (Bad-Homburg, Germany)
Reports To:
Head of QM/SCM
FTE
100% (40 hours/week)
We are Celltrion Healthcare.
Celltrion Healthcare conducts worldwide marketing, sales, and distribution of biological medicines through an extensive global network that spans more than 120 different countries. Celltrion Healthcare provides REMSIMA, the world's first biosimilar monoclonal antibody (mAb) approved by the European Medicines Agency (EMA) for the treatment of autoimmune disease, and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world. Celltrion Healthcare believes that every patient deserves access to the treatments they need. Based on this belief, Celltrion Healthcare has been steadfast in our mission to meet the needs of patients who previously had limited access to advanced therapeutics, since our inception in 1999. Celltrion Healthcare Deutschland GmbH is a high-growth, fast-paced small organization. The ability to be productive and successful in an intense work environment is critical.
Position Summary:
The position of the Sr. Associate Regulatory Affairs is newly created to ensure regulatory requirements in accordance with legal requirements. Fulfillment of regulatory tasks, as well as definition, implementation, maintenance, and continuous development of QM processes in the pharmaceutical wholesale business.
What you can expect:
Duties and Responsibilities:
Creation, Coordination, Documentation (archiving), Maintenance, and follow-up on the following:
1. Close cooperation and collaboration with Global Regulatory Affairs and implementation of the global guidelines at the national level
2. Support global regulatory to ensure efficient and compliant business processes and environment in cooperation with cross-functional teams.
3. Supporting the update of all regulatory relevant documents and materials at the national level. Ensure timely availability of the requested materials.
4. Support product approval and implementation of all necessary processes on a national level.
5. Provide and implement regulatory information and updates. Follow the development and emergence of new regulatory requirements & trends for pharmaceuticals.
6. Training of the German team on proposed/present EMA guidelines and regulations and ensuring compliance with internal and external regulatory standards.
7. Artwork-Management
8. Life-Cycle and Change Management
9. Implementation of changes and updates of product information, SMPC, and other necessary documents.
10. Assessment of marketing texts and advertising materials (HWG)
11. Ensuring regulatory compliance
12. Close cooperation and cross-functional collaboration with Quality Management, Medical, Pharmacovigilance and Marketing
13. Maintain a clear and standardized filing/archiving system for documents and correspondence, and support corresponding functions in document management.
Requirements:
A. Qualifications/Experiences:
B. Personality:
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