Regulatory Affairs Manager 8/31/2016
Lake Forest, IL
JOB DESCRIPTIONAPPLY * Regulatory Affairs Experience in pharmaceutical industry.
* Minimum of 5years + 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.
* 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, and 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.