Senior Manager – Regulatory Affairs
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Job Description
Senior Manager overseeing global regulatory strategy for Avalyn's inhaled drug-device combination products. Collaborating with cross-functional teams for regulatory submissions and health authority interactions.
Responsibilities:
- Support development and execution of global regulatory strategy
- Oversee global regulatory submissions and health authority interactions
- Lead regulatory activities for assigned development programs
- Collaborate with cross-functional teams to integrate regulatory considerations
Requirements:
- Experience in regulatory affairs for drug-device combination products
- Experience with rare disease drug development
- Proven track record in late-phase clinical development
- Experience in global regulatory submissions
- Strong understanding of regulatory strategy and compliance
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