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Senior Reg Affairs Specialist - CTA Clinical Research Field
Reg Affairs Specialist - CTA Clinical Research Field
Regulatory affairs specialist with expertise in clinical research and technical skills in Python, Node.js, Machine Learning, and AWS.
About the role
As a Senior Reg Affairs Specialist - CTA (Clinical Research Field), you will be responsible for ensuring compliance with regulatory requirements and guidelines in the clinical research field. You will work closely with cross-functional teams to develop and implement regulatory strategies, provide regulatory support, and ensure compliance with regulatory requirements.
Key Responsibilities:
- Develop and implement regulatory strategies to ensure compliance with regulatory requirements and guidelines.
- Provide regulatory support to cross-functional teams, including clinical research teams, to ensure compliance with regulatory requirements.
- Stay up-to-date with regulatory changes and updates, and communicate changes to relevant stakeholders.
- Collaborate with internal stakeholders to develop and implement regulatory training programs.
- Ensure compliance with regulatory requirements and guidelines in the clinical research field.
Requirements:
- 5+ years of experience in regulatory affairs, preferably in the clinical research field.
- Strong knowledge of regulatory requirements and guidelines in the clinical research field.
- Excellent communication and project management skills.
- Ability to work in a fast-paced environment and prioritize multiple tasks.
- Strong analytical and problem-solving skills.
Skills
pythonnodejsmachine learningaws