Remote: Sr. Regulatory Affairs Lead (232438)

Clinical Research & Clinical Affairs | Life Sciences & Technology
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Job Description 

Our client is looking for a Sr. Regulatory Affairs Lead with 10+ years of experience preferably from an Oncology background with a dual focus in Pharmaceuticals and Medical Devices. The Client is currently developing one of their vendors (USR) so some regulatory oversight will be required and would need someone to submit a fast track designation for one of their products. One of their protocols will require a discussion with the FDA so prior FDA facing experience would be beneficial, as this regulatory professional would need to discuss with the FDA so they will accept what would be done. This FDA meeting will need to be set up to discuss the development of imaging device. Other regulatory submission (IND,NDA,BLA,MAA) experience would be great have for future potential needs.

Required Skills 

Regulatory Affairs
Imaging Device Experience
Device Development
Regulatory Submissions (IND/NDA/BLA/MAA)
FDA Meetings / FDA Facing
Fast Track Designation
Oncology

BS/BA
MS/MA

Remote: Sr. Regulatory Affairs Lead (232438)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Remote

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