Division Spotlight: Regulatory Affairs & Compliance

Posted on May 12, 2021

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Lonna Tucker, RAC, Director of Regulatory Affairs and Compliance, took time to chat with us and provide insight into the Avanti's Regulatory Affairs & Compliance Division!

What is a new/exciting project or initiative that the Regulatory Team is working on?

The Regulatory Team has been extensively involved in providing support to customers for regulatory filings associated with COVID-19 vaccines at various stages of development, from early phase clinical to commercial.

Describe the general process/responsibilities that the Regulatory Team goes through to ensure that our manufacturing complies with state, federal, and international regulations.

The Regulatory Division oversees regulatory activities within the company, supplies information to support business decisions, and provides support to customers for their specific requirements. Regulatory Affairs (RA) is responsible for the generation and maintenance of over 50 master files for more than 35 different Avanti products.

They serve as a resource both internally and externally regarding the regulations for a wide variety of products and applications. RA is the liaison to customer counterparts and is a member of project teams. RA works closely with Quality Assurance and Quality Control in order to ensure company compliance. They evaluate changes to manufacturing, analytical methods, and validated systems for regulatory impact to the company and to customer’s regulatory filings and assist in risk assessments and evaluations. They interpret regulations in order to help develop regulatory strategy and direction for the organization.

RA monitors regulatory policies and procedures, provides guidance for compliance with regulations and current thinking, and monitors business news and trends that may impact the company. Pertinent items are communicated to the appropriate personnel within the company to support and guide regulatory and business strategy within the organization.

How is the Regulatory Team interacting/collaborating with the broader Croda family so far?

Rick Rucoba (Croda, Princeton) was assigned as the Regulatory Integration liaison in August 2020, and he introduced me to Helen Albans, the Regulatory Manager at Croda Leek. Rick and I still speak on a weekly basis, and Helen and I collaborate frequently since we are both involved in regulatory submissions and support of lipid products for vaccines. I meet on a regular basis with colleagues from Avanti and Leek Quality and Regulatory to discuss mutual issues, collaborations, and sharing opportunities. I participate in a Croda Global Health Care Regulatory group that has been meeting every 2 months since December 2020, and participated in the global PAD/PSRA event in March 2021. I’ve also had interactions with Croda Research and Business Development colleagues.

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