Regulatory Affairs Manager (f/m) Vienna Austria,
AOP ORPHAN (company)
As part of our Regulatory Affairs team you will play a key role in Life Cycle Management of existing approvals and submission of new regulatory projects.
Ready for an ambitious job?
- You are planning and coordinating the compilation of global regulatory submission documents according to country specific requirements
- Prepare all labelling documents and track timely submission at the authorities
- You manage change control processes and oversee post-approval activities
- You are responsible for regulatory data management (DocuBridge)and electronical xEVMPD (IDMP) reporting
Able to align?
- You enjoy working in a high-performing international environment
- You provide regulatory know-how to Project Teams involved in the development of new products
- You are a team player and like to work cross-functionally and with external partners
Looking for an agile environment?
- You prefer a high degree of independence and responsibility for assigned projects
- You enjoy to work in a growing international company introducing solutions for rare diseases to new markets
- You have a pro-active attitude, the ability to develop new concepts and a creative approach to problem-solving
- University degree in Natural Science/, Pharmacy, Medicine or comparable education
- 3-5-year Regulatory Affairs experience in the pharmaceutical industry
- In-depth knowledge of international regulatory requirements
- Ability to strategically plan and manage multiple projects
- Attention to detail and ability to prioritize
- Strong communication skills to liaise with internal and external partners with different cultural background in English and German
The gross monthly salary provided for this function is a minimum of
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