Senior Regulatory Affairs specialist - Katalyst Healthcares & Life Sciences
San Jose, CA 94088
About the Job
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 5 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.
- Minimum of 5 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.
Source : Katalyst Healthcares & Life Sciences
