Regulatory Submissions Consultant
Company Name:
Brilliant Leap
At Brilliant Leap we bring together the finest 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 Regulatory professionals who have experience working with submissions and compliance activities. You should be a team player, enjoy wearing many hats and find satisfaction in getting the job done. We compensate those who have extraordinary abilities and experience extremely well.
At present we have a long term consulting opportunity to support the Regulatory submissions team at one of our client sites. The individual should be experienced with preparing routine submissions including Annual Reports, New Protocol Submissions, Protocol Amendment Submissions, etc.
Proven experience with the activities listed below is also preferred:
Acting a primary liaison with DRA Operations to ensure accurate and timely submissions to Health authorities.
Coordinating the compilation and review of Briefing Books for Regulatory Health Authority meetings.
Facilitating the timely delivery of sections to compile the IND/IMPD (CTAs) and NDA/MAA/CTD for Health Authority submissions.
Assisting in the preparation of regulatory deliverables (i.e. power-point presentations, excel spreadsheets, informal tracking for deliverables)
Obtaining 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
At Brilliant Leap we bring together the finest 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 Regulatory professionals who have experience working with submissions and compliance activities. You should be a team player, enjoy wearing many hats and find satisfaction in getting the job done. We compensate those who have extraordinary abilities and experience extremely well.
At present we have a long term consulting opportunity to support the Regulatory submissions team at one of our client sites. The individual should be experienced with preparing routine submissions including Annual Reports, New Protocol Submissions, Protocol Amendment Submissions, etc.
Proven experience with the activities listed below is also preferred:
Acting a primary liaison with DRA Operations to ensure accurate and timely submissions to Health authorities.
Coordinating the compilation and review of Briefing Books for Regulatory Health Authority meetings.
Facilitating the timely delivery of sections to compile the IND/IMPD (CTAs) and NDA/MAA/CTD for Health Authority submissions.
Assisting in the preparation of regulatory deliverables (i.e. power-point presentations, excel spreadsheets, informal tracking for deliverables)
Obtaining 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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