Responsibilities :
- Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products.
- Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics and operational recommendations for product development.
- Develop regulatory submission strategies in agreement with defined product development objectives.
- Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned Investigational New Drug (IND) and New Drug Applications (NDA) projects.
- Prepare and submit IND and NDA applications, as well as various amendments and supplements.
- Minimum of years + experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch.
- Prior management experience, with a demonstrated capability to lead and motivate staff is essential.
- Demonstrated strategic development capabilities related to new drug development and commercial support activities are critical.
Requirements :
- Minimum of years + experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch.
- Prepare and submit IND and NDA applications, as well as various amendments and supplements.
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