Regulatory Affairs Specialist
4 weeks ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Athsai. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing global regulatory strategies to support the development of biomarkers, companion diagnostic tests, and digital health products.
Key Responsibilities:
- Develop and implement global regulatory strategies to support the development of biomarkers, companion diagnostic tests, and digital health products.
- Lead global regulatory submissions and interactions with Health Authorities.
- Collaborate with cross-functional teams to develop regulatory strategies and ensure compliance with global regulatory requirements.
- Provide input into the development of protocol synopses and protocols.
- Contribute to the development of target labeling.
Requirements:
- Bachelor's degree required; advanced scientific degree preferred.
- 5 years of experience in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience.
- Experience in successfully leading teams and utilizing leadership techniques to drive a team through the stages of team development.
- Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives.
- Experience with clinical trial assays (CTA) in drug clinical trials and communicating between Diagnostic sponsor and Drug sponsor.
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