Regulatory Submissions Manager - (US-TX-The Woodlands - 77393)

Minimum Education: Bachelors
Job Type: Full Time
Jobcode: 2912
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Our client is a rapidly growing biopharmaceutical company based in The Woodlands, Texas. Using their state of the art technology, they have discovered the physiological and behavioral functions of nearly 5,000 genes. They have an exciting goal of advancing 10 drug candidates into human clinical trials by the year 2010. This is a great opportunity for someone looking for personal growth and a challenge!

Job Responsibilities:
1) Manage and maintain existing IND/CTA submissions
2) Prepare amendments and annual reports in compliance with FDA regulations
3) Work with CROs for ex-US submissions
4) Coordinate with functional leads in various disciplines to assemble documents, including writing, reviewing, editing and publishing submissions
5) Assist with pre-IND meeting briefing packages and initial IND submissions for new programs
6) Represent the department on multi-disciplinary development sub-teams
7) Mentor personnel
8) Perform other duties as assigned

Job Requirements:
1) Bachelor’s degree in a scientific discipline
2) Minimum 5 years of experience in a regulatory position within a biotech or pharmaceutical company or a CRO
3) Experience in electronic filing submissions preferred
4) Excellent organizational and communication skills
5) Ability to work in a team-oriented environment

Applicants are encouraged to apply directly by going to: http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-02912.html