Salt Lake City, Utah
Director Pharmaceutical Regulatory Affairs Job Opening in Salt Lake City, Utah - There are many types of biopharma startups. Most have such a long way to go you won?t see the tunnel, much less the light at the end of it, for many years. And a very few are already in the glow of the light from the tunnel. This is such a company. We have a highly skilled and sought-after team of professionals dedicated to bringing to market a novel and unique product that has the potential of having major, positive impacts within a large sector of healthcare. We need more of such people.
Reporting to the VP of Regulatory Affairs, and based in Salt Lake City, the Director of Pharmaceutical Regulatory Affairs and Quality will join in the continuing development of regulatory strategy. This is a combo device/pharma product and the Director will take the lead ? be the expert - in pharmaceutical regulatory filings and practices including IND?s, NDAs, ex-US filings, setting up regulatory documentation, documentation tracking, and other related duties. This will also include the development and implementation of the quality management system and strategies to ensure compliance with established standards and agency guidelines as becomes necessary.
Are you qualified to join this team? We are looking for an accomplished expert will qualifications and experience including:
a life sciences related degree
strong pharmaceutical regulatory experience, including IND and NDA submissions
regulatory work with clinical trials
exposure and familiarity with medical device regulatory requirements
FDA interaction experience
familiarity with quality systems
Located in Salt Lake City or interested in relocating there
Company
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Not sure this is right for you? If you have the basic qualification, yet are uncertain about this position, go ahead and send your contact information and ask for a confidential opinion . We do not refer candidate's information without their prior and enthusiastic approval.
Job Type: Full-time
Job Location:
Salt Lake City, UT
Required education:
Bachelor's
Required experience:
Pharmaceutical Regulatory Affairs: 1 year
NDA: 1 year
clinical trials: 1 year
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