CMC Regulatory Expert Global Pharmaceutical Company Hungary
Job Summary
For our multinational pharmaceutical partner we are in search of a CMC Regulatory Manager to join this exciting role supporting the companys growth which includes a major site-to-site technology transfer project in Hungary.
Key Responsibilities:
- Overseeing the preparation of regulatory submission documents.
- Ensuring regulatory compliance for pharmaceutical products at all stages of their lifecycle
- Collaborating with internal teams (both parent and subsidiary companies) and external experts.
- Providing professional support for new marketing authorization applications and ongoing regulatory maintenance tasks
- Addressing regulatory queries and preparing comprehensive responses
- Handling administrative and documentation-related tasks within the marketing authorization dossier management system
Requirements:
- Degree in Life Sciences (Biology Chemistry Pharmacy stb.)
- Fluent in English and Hungarian
- At least 2 years of regulatory experience preferably in CMC (writing or reviewing)
Should you be interested please do not hesitate to submit your professional CV.
Key Skills
- Sales Experience
- B2B Sales
- Primary Care Experience
- Biotechnology
- Account Management
- Territory Management
- Computer Literacy
- Outside Sales
- Biomedical
- Botox Experience
- negotiation
- Compounding Medications