Associate Director Regulatory Affairs
Job Summary
Leading the development and continuous improvement of global pharmacovigilance signal detection processes, the full-time Associate Director Regulatory Affairs will ensure compliance with Health Authority requirements and serve as a subject matter expert while working remotely.
Key responsibilities
- Oversee global pharmacovigilance signal detection and management processes
- Collaborate with cross-functional teams to maintain compliant processes and provide vendor oversight
- Develop and deliver training related to signal detection and management, while mentoring junior scientists
Required qualifications
- Bachelor's degree in Life Sciences, Healthcare, Pharmacy, Medicine, or a related discipline
- Experience in pharmacovigilance and medical safety sciences
- Knowledge of EU pharmacovigilance regulations and regulatory inspection expectations
- Experience with signal detection methodologies and risk-benefit assessment
- Strong background in cross-functional collaboration within pharmaceutical or biotechnology organizations
Complete Job Description
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