Regulatory Submissions Consultant
Company Name:
Brilliant Leap, a div of Selective Search, Inc.
At Brilliant Leap we bring together superior Regulatory Submissions professionals with the finest Life Science and Biotechnology companies on the planet - whose common mission is to bring therapies to market that improve health and well-being.
We are currently searching for a Regulatory Professional who has experience working with submissions and compliance activities. You should be a team player, enjoy diversified responsibilities, and find satisfaction performing an exceptional job. We compensate those who have extraordinary abilities/experience extremely well.
You should have experience with preparing routine submissions including Annual Reports, New Protocol Submissions, Protocol Amendment Submissions, etc.
Proven experience with the activities listed below is also preferred:
Act as a primary liaison with DRA Operations to ensure accurate and timely submissions to Health authorities.
Coordinate the compilation and review of Briefing Books for Regulatory Health Authority meetings.
Facilitate the timely delivery of sections to compile the IND/IMPD (CTAs) and NDA/MAA/CTD for Health Authority submissions.
Assist in the preparation of regulatory deliverables (i.e. power-point presentations, excel spreadsheets, informal tracking for deliverables)
Obtain up-to-date Regulatory Intelligence and other regulatory support Information Review and approval of Clinical Supplies / Labels (US).
To be considered for this position, please e-mail your resume to . Feel free to follow-up with a phone call. Virginia can be reached at 973-744-8164Estimated Salary: $20 to $28 per hour based on qualifications.
Brilliant Leap, a div of Selective Search, Inc.
At Brilliant Leap we bring together superior Regulatory Submissions professionals with the finest Life Science and Biotechnology companies on the planet - whose common mission is to bring therapies to market that improve health and well-being.
We are currently searching for a Regulatory Professional who has experience working with submissions and compliance activities. You should be a team player, enjoy diversified responsibilities, and find satisfaction performing an exceptional job. We compensate those who have extraordinary abilities/experience extremely well.
You should have experience with preparing routine submissions including Annual Reports, New Protocol Submissions, Protocol Amendment Submissions, etc.
Proven experience with the activities listed below is also preferred:
Act as a primary liaison with DRA Operations to ensure accurate and timely submissions to Health authorities.
Coordinate the compilation and review of Briefing Books for Regulatory Health Authority meetings.
Facilitate the timely delivery of sections to compile the IND/IMPD (CTAs) and NDA/MAA/CTD for Health Authority submissions.
Assist in the preparation of regulatory deliverables (i.e. power-point presentations, excel spreadsheets, informal tracking for deliverables)
Obtain up-to-date Regulatory Intelligence and other regulatory support Information Review and approval of Clinical Supplies / Labels (US).
To be considered for this position, please e-mail your resume to . Feel free to follow-up with a phone call. Virginia can be reached at 973-744-8164Estimated Salary: $20 to $28 per hour based on qualifications.
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