
Senior Regulatory Affairs Professional
2 semanas atrás
Patient access to medicines and vaccines requires careful planning and execution. As a Senior Regulatory Affairs professional, you will play a crucial role in ensuring our products meet the highest regulatory standards.
Main Responsibilities- We manage documentation systems to maintain accurate records and ensure compliance with regulatory requirements.
- You will coordinate the assembly of regulatory dossiers and communicate documentation standards to internal stakeholders.
- Analyze tender reports and prepare for discussion with key stakeholders to improve operations.
- Review documents and dossiers related to submissions of new product registration, line extensions, post-approval changes, and License Renewals.
- Support the timely preparation of reports, such as the Monthly Operating Report.
- You are responsible for data entry and quality control tasks associated with global regulatory systems.
- Bachelor's Degree.
- 3+ years of experience in Regulatory Affairs or a related function within the pharmaceutical sector.
- Ability to oversee and provide Quality Control support for others' work.
- Knowledge of National and Clinical Trials legislation, and guidelines.
- Ability to interpret and relay technical information, work with accuracy, and provide attention to detail.
We value diversity and inclusion, seeking a plural, just, and equitable work environment.
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Regulatory Affairs Specialist
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Associate Director, Regulatory Affairs
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Analyst Regulatory Affairs
4 semanas atrás
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