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Regulatory Affairs Consultant
3 months ago
Regulatory Affairs Consultant Position at XYZ Pharmaceuticals
- Over 8 years of experience managing life cycle of approved drug products such as tablets, syrups, and injectables for EU market
- Deep understanding of regulatory framework and regional trends for various types of applications
- Leading and participating in the planning and delivery of regulatory submissions on a global and/or regional scale
- Familiarity with EU/US regulatory procedures and post-approval requirements
- Experience in handling CMC-related health authority queries
- Knowledge of global pharmaceutical legislation and guidance related to regulatory aspects in ICH countries
- Collaborating closely with cross-functional team members
- Developing and maintaining submission delivery plans
- Preparing and submitting safety variations to Health Authorities
- Familiarity with Regulatory Information Management Systems like Veeva Vault is a plus
- Strong communication and ability to work independently