Manager / Director Regulatory Affairs - (US-NJ-Newark - 07199)

Compensation: $100K - $100K / Year
Minimum Education: Bachelors
Job Type: Full Time
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Job Title: Manager/Director, Regulatory Affairs

Description:
The Manager/Director, Regulatory Affairs will provide US regulatory stewardship for the assigned development candidate(s), serving as the companies' regulatory liaison with FDA Division staff responsible for the assigned product(s).

Responsibilities include the following: * Develop US regulatory strategy in support of the Global Regulatory Plan
* Provide US regulatory intelligence assessments in support of assigned therapeutic area
* Contribute to development of IND/NDA original documents and amendments intended for submission to FDA to ensure compliance with US regulatory strategies and requirements
* Manage FDA meetings for assigned product, including development of required documentation
* Collaborate with the Global Regulatory Team and Clinical Study Team for assigned project

Qualifications:
Candidates should have a minimum of a Pharm D or undergraduate degree in a life science with 3 - 5 years of US pharmaceutical industry regulatory experience. An advanced degree is a plus. Required qualifications include demonstration of successful submissions/management of INDs/NDAs/BLAs and extensive knowledge of US FDA regulations and guidelines, including ICH. Sound planning and strategic skills, as well as excellent leadership, communication, and organizational skills are also required.


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