Pace Analytical Services, Inc. Regulatory Specialist - Pharma in Maplewood, Minnesota
This candidate will provide regulatory support to our customers through documentation of Drug Master Files (DMF). Some regulatory experience in a healthcare environment is preferred. This is a great opportunity for a candidate who is looking to work outside of the lab with pharmaceutical information.
Documentation work with DMFs such as: prepare DMF amendments, draft DMFs or sections of them, and review for completeness
Prepare DMF annual reports
Send notification letters and emails, and track responses
Convert files into current electronic format (eCTD publishing)
Other organizational or tracking duties as needed
Bachelor's degree in scientific field or degree in regulatory affairs
1-2 years of regulatory experience preferred
Lab and/or regulatory experience in a GMP or ISO environment
Experience with controlled document databases or software a plus
Candidate should be a team player, highly productive, self-motivated, and results-oriented
Strong organizational skills and initiative to follow up with others to obtain information
Possess problem solving skills along with excellent written and verbal communication skills
Ability to manage multiple projects simultaneously
Our Scientific Professional Services division partners with companies that have scientific needs both inside and outside of the laboratory. We hire quality candidates for our lab and regulatory teams so that our customers have an elite workforce supporting their company. Our Scientific Recruiters are passionate about finding a position that is the right fit for you.
We’re proud to offer careers that are both challenging and meaningful- as well as a comprehensive benefits package to all of our regular, full-time employees. If you work with us, you’ll be part of a dynamic team focused on delivering science better.
Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity.
External Company Name: Pace Analytical Services, LLC
External Company URL: http://www.pacelabs.com/
Street: 3M Center