Lacey Carlson Email & Phone Number | Detail-oriented and highly skilled Regulatory Affairs professional with extensive experience in pharmaceutical regulatory science and specialized expertise in Veeva Vault RIM implementation and management. My career spans several years at Upsher Smith Laboratories, where I've consistently driven regulatory compliance and operational efficiency through strategic insights and technical proficiency. As a Regulatory Affairs CMC Specialist at Upsher Smith Laboratories since 2018, I've been dedicated to ensuring the accuracy, completeness, and compliance of regulatory submissions, including ANDAs, amendments, supplements, PADERs, and annual reports. My commitment to staying up-to-date with FDA regulations and guidelines has allowed me to identify potential impacts on products, business practices, and ongoing projects. With a passion for developing effective regulatory strategies, I've contributed significantly to product development, lifecycle management, and post-approval changes, all aligned with company objectives and regulatory standards. My role has also entailed meticulously managing submission timelines and collaborating seamlessly with cross-functional teams to align CMC strategies with project goals. My proficiency in Veeva Vault RIM has been a pivotal asset in my career journey. I spearheaded the successful implementation and deployment of Veeva Vault RIM, orchestrating the seamless migration of regulatory data and documents from legacy systems. Collaborating closely with cross-functional teams, I designed and configured Veeva Vault RIM to meet specific regulatory needs, streamlining processes and enhancing efficiency. My dedication extended to delivering comprehensive training sessions that empowered end-users to proficiently navigate and utilize the system. In addition, my background as a Technical Writer equipped me with the skills to author and edit a range of documents, from SOPs and work instructions to protocols and annual product reports. My commitment to clarity, accuracy, and regulatory compliance has consistently yielded high-quality documentation that adheres to industry standards. My areas of expertise encompass Veeva implementation and configuration, training and user support, regulatory strategy and compliance, cross-functional collaboration, regulatory submissions, stakeholder communication, project and timeline management, data reporting and analytics, SOP development and maintenance, technical writing, document and data management, as well as process auditing and improvement.

Lacey Carlson

Detail-oriented and highly skilled Regulatory Affairs professional with extensive experience in phar...
Minneapolis, Minnesota, United States

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Lacey Carlson’s Email lacey.carlson@upshersmith.com

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Lacey Carlson’s Location Minneapolis, Minnesota, United States

Lacey Carlson’s Current Industry Upsher Smith Laboratories Upsher Smith

Lacey Carlson’s Prior Industry Bioamber | Minnesota State University Mankato | Csc Computer Sciences

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Work Experience

Upsher Smith Laboratories

Regulatory Affairs Cmc Specialist

2019-01-01 00:00:00 - Present

Upsher Smith

Veeva Rim Administrator

2018-08-01 00:00:00 - Present

Bioamber

Research Scientist

2012-01-01 00:00:00 - 2013-01-01 00:00:00

Minnesota State University Mankato

Graduate Research Assistant

2008-01-01 00:00:00 - 2012-01-01 00:00:00

Csc Computer Sciences

Environmental Publications Database Specialist

2007-01-01 00:00:00 - 2008-01-01 00:00:00

Skills

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Languages

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FAQ About Lacey Carlson

Lacey Carlson is located at
Minneapolis, Minnesota, United States

Lacey Carlson is a Detail-oriented and highly skilled Regulatory Affairs professional with extensive experience in pharmaceutical regulatory science and specialized expertise in Veeva Vault RIM implementation and management. My career spans several years at Upsher Smith Laboratories, where I've consistently driven regulatory compliance and operational efficiency through strategic insights and technical proficiency. As a Regulatory Affairs CMC Specialist at Upsher Smith Laboratories since 2018, I've been dedicated to ensuring the accuracy, completeness, and compliance of regulatory submissions, including ANDAs, amendments, supplements, PADERs, and annual reports. My commitment to staying up-to-date with FDA regulations and guidelines has allowed me to identify potential impacts on products, business practices, and ongoing projects. With a passion for developing effective regulatory strategies, I've contributed significantly to product development, lifecycle management, and post-approval changes, all aligned with company objectives and regulatory standards. My role has also entailed meticulously managing submission timelines and collaborating seamlessly with cross-functional teams to align CMC strategies with project goals. My proficiency in Veeva Vault RIM has been a pivotal asset in my career journey. I spearheaded the successful implementation and deployment of Veeva Vault RIM, orchestrating the seamless migration of regulatory data and documents from legacy systems. Collaborating closely with cross-functional teams, I designed and configured Veeva Vault RIM to meet specific regulatory needs, streamlining processes and enhancing efficiency. My dedication extended to delivering comprehensive training sessions that empowered end-users to proficiently navigate and utilize the system. In addition, my background as a Technical Writer equipped me with the skills to author and edit a range of documents, from SOPs and work instructions to protocols and annual product reports. My commitment to clarity, accuracy, and regulatory compliance has consistently yielded high-quality documentation that adheres to industry standards. My areas of expertise encompass Veeva implementation and configuration, training and user support, regulatory strategy and compliance, cross-functional collaboration, regulatory submissions, stakeholder communication, project and timeline management, data reporting and analytics, SOP development and maintenance, technical writing, document and data management, as well as process auditing and improvement.

Lacey Carlson currently works in the Upsher Smith Laboratories | Upsher Smith |

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Lacey Carlson has prior
experience in the following industries:
Bioamber | Minnesota State University Mankato | Csc Computer Sciences

Lacey Carlson has the following professional experience:
Upsher Smith Laboratories | Upsher Smith | Bioamber | Minnesota State University Mankato | Csc Computer Sciences