Senior Regulatory Licensing Analyst
Azenta Life Sciences

At Azenta, 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.

Azenta Life Sciences is a global leader in the life sciences space with headquarters in Burlington, MA, and offices and operations worldwide. We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally. We provide unparalleled capabilities with our lab analysis, sample management and storage services, informatics software, and consumables, with the largest installed base managing over 1 billion samples globally.

How you'll add value:

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

At Azenta, we are a part of the science behind the COVID vaccine and we are committed to the health and safety of our employees, customers and the communities where we live and work. To protect our coworkers, clients, families and friends, we have implemented a policy where all of our US employees must be fully vaccinated (which includes taking the booster) or have requested and received an approved medical/religious accommodation prior to their first day of work.

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