Tutor profile: Erica S.
Regulatory Affairs Associate, CMC and Labeling
Hi! My name is Erica Shepard and I am an experienced Regulatory Affairs Specialist with a demonstrated history of working in the pharmaceuticals industry. Skilled in eCTD, GMP practices, Good Laboratory Practices (GLP), New Drug Application (NDA) submissions, Abbreviated New Drug Application (ANDA) submissions, Biopharmaceuticals, Regulatory Requirements, Adobe Acrobat, and Veeva Vault. Detail-oriented, organized, and enthusiastic graduate of biochemistry with a passion for medicine and healthcare. My biochemistry degree consisted of the...
Following graduation in 2015, I was hired to be the Organic Chemistry Lab Instructor for a semester until I began my career in pharmaceuticals. I instructed all lab sessions- I demonstrated what the students would be performing for each lab period, was available for any questions they had throughout the lab, had office hours to provide extra help on lab reports, and graded all lab reports. At the same time, I also tutored students aged elementary through high school on various science, mathematic, and English subjects.
2011 - 2015
United Therapeutics Corporation, Regulatory Affairs Associate, CMC and Labeling
2019 - Present
• Performs regulatory CMC and Labeling activities for assigned products and territories, including creating and updating quality sections of regulatory filings and review of quality submission documents to ensure consistency with related filings and regulatory requirements • Interacts with UT manufacturing and quality groups, contract and partner organizations, as necessary, regarding CMC and labeling regulatory issues • Collaborates with regulatory CMC and Labeling Manager on regulatory aspects of clinical and commercial product labeling for...
X-GEN Pharmaceuticals, Inc., Regulatory Affairs Specialist
2016 - 2019
-Create, monitor and track regulatory submissions (ANDAs) and related maintenance documentation (amendments, supplements, annual reports, etc.) to meet submission commitments and deadlines - Develop printed product labeling and core donate labeling changes and manage communication with CM and labeling artwork supplier. Coordinate to filing of all labeling changes -Provides strategic, tactical and support for working within regulations to expedite the development and delivery of safe and effective healthcare products -Effective communicator in...
Elmira College, Organic Chemistry Lab Associate
2015 - 2016
-Provide quality instruction in Organic Chemistry concepts and proper laboratory protocols, procedures, and techniques. -Maintain a safe laboratory environment and ensure proper handling of waste materials. Maintain awareness and enforce fire and health and safety regulations applicable to the laboratory environment. -Provide advice and support to students. -Grade laboratory worksheet assignments. -Inform students of their progress by promptly returning graded laboratory assignments -Contribute to the development, planning and implementation...
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