Senior Global Regulatory Affairs Specialist at a clinical research organisation seeking an experienced regulatory professional to design clinical trials, interpret medical data, and advance innovative treatments. The role involves developing global regulatory strategies, managing submissions, and ensuring compliance with evolving requirements across multiple countries.
Responsibilities
- Develop and execute global regulatory strategies for clinical trial and marketing authorization submissions
- Provide regulatory guidance and support to cross-functional teams throughout drug development
- Manage regulatory submissions and interactions with health authorities
- Ensure compliance with global regulatory requirements and standards
- Monitor regulatory intelligence to track changes in regulations and guidelines
Requirements
- Bachelor's degree in scientific discipline or related field
- Minimum 5 years regulatory affairs experience in pharmaceutical or biotechnology
- Strong knowledge of global regulatory requirements and guidelines
- Excellent written and verbal communication skills
- Ability to work independently and collaboratively in fast-paced environment
Vacancy posted 6 days ago
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