Regulatory Affairs Specialist

Job DetailsLevelExperiencedJob LocationMinneapolis - Minneapolis, MNPosition TypeFull TimeEducation LevelAssociate's DegreeTravel PercentageNegligibleJob ShiftDayDescriptionBy joining the Bio-Techne team, you will have an impact on future cutting-edge research. Bio-Techne and all of its brands provides tools for researchers in Life Sciences and Clinical Diagnostics. Position Summary: The responsibilities of the Regulatory Affairs Specialist are to assist senior regulatory staff with the development of regulatory submissions and pre-publishing activities for electronic filings. Other functions include tracking and drafting annual updates of regulatory filings, amendments, supporting cross-reference requests and maintaining and organized file structure for each product filing.Key Responsibilities: Locate and collect documents to support regulatory submissionsCompile regulatory filings, reports and other submissionsPerform pre-publishing tasks to ensure timely set up in eCTD format and complete publishingParticipate in quality control review activities to support submissions and other documentsPerform post submission tasks including organization and archival of regulatory filings and effective maintenance of supporting documents including appendices and supporting correspondenceSupport customer questions and requests for cross reference letters in a timely mannerProvide support regarding change controls which impact regulatory filingsRepresent regulatory team in multi-functional team discussions or customer auditsPerforms additional duties as assignedQualificationsEducation and Experience: Position requires a Bachelor's degree. Three to five years of related laboratory or quality assurance experience or related master's degree. Attention to detail and organizational skills are required. Working knowledge of Microsoft Word and Excel are required. Computer entry, typing, or electronic document filing skills are desirable. Must be able to work in a fast-paced environment, multitask, and have excellent communication skills, both verbally and in writing.Knowledge, Skills, and Abilities: Knowledge of regulatory guidance, as applicable.Skills in assisting customers in a professional manner.Skills in problem solving; including the ability to identify and appropriately evaluate a course of action. Ability to act independently on routine assignments or projects.Ability to pay attention to details and perform at a high-level of accuracy.Ability to work independently and with a team.Ability to work hours that conform to standard business operations