Sr. Regulatory Licensing Analyst

Location: 
Indianapolis , IN

Brand:   Brooks Automation

REQ ID:   R6414

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Overview

At Azenta, formally Brooks Life Sciences, new ideas, new technologies and new ways of thinking are driving our future. Our customer-focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.

 

All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and Integrity. At Azenta, we are dedicated to enabling life sciences organizations around the world to bring impactful breakthroughs and therapies to market – faster.

Summary

The Sr. Regulatory Licensing Analyst is responsible for compliance with federal, state, local and regulatory licensure regulations, including but not limited to: VAWD, State 3PL, Good Tissue Practices (GTP), NRC, State Tissue Bank and FDA certifications.  The position is also responsible for filing and submitting license applications and renewals for those regulations.

Essential Functions

Manages pharmaceutical distribution facility licensing required to distribute drugs. Manages 3PL partner facility and pharmacy licenses required to distribute drugs. Manages regulatory GxP licensing, filings and certifications. Ensures compliance with local, state and federal laws and regulations. Identifies risks associated with licensing activities and communicates effectively to management Works with the State Government Boards to remain current on state and local rules and regulations for the distribution of drugs. Reports changes that affect BLS or 3PL partners to management. Supports management of policies governing 3PL distribution and GxP licensing. Works with the 3PL partners to obtain sourcing and ensure compliance in each facility.

Academic & Work Experience

  • Bachelor’s Degree in Life Sciences

  • 2 years of experience with pharmaceutical/medical device licensing and/or GxP licensing

  • Knowledge of pharmaceutical/medical device distribution Operations processes

  • Knowledge of FDA regulations for prescription drugs and medical devices (21 CFR)

Key Skills and Position Competencies

  • Organized and detail oriented

  • High level of initiative and ability to prioritize work independently

  • Problem solving

  • Experience working on team projects with tight timelines

  • Ability to be highly effective at communication across functional areas

  • Proficient with Microsoft office suite (Excel, Word, PowerPoint)

  • Ability to work within regulations regarding potentially infectious materials

  • Basic understanding of biological sample storage

EOE  M/F/Disabled/VET

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