Secura Bio is seeking a Director/Senior Director of Regulatory Affairs to develop and execute regulatory strategies for product development and commercialization. The role will oversee all regulatory activities and ensure compliance with global standards and timely product approvals.
Requirements
- Advanced degree in life sciences, pharmacy, or related field
- 10+ years of progressive experience in regulatory affairs
- Minimum of 5 years experience in the hematology/oncology field
- Demonstrated track record of successful regulatory submissions and agency interactions
- Comprehensive understanding of FDA, EMA, and other major health authority regulations
- Strong leadership abilities
- Excellent communication and interpersonal skills
- Strategic thinking
- Ability to work collaboratively with internal and external stakeholders
- Deep knowledge of GxP requirements and their implementation
