erica shepard
regulatory affairs associate, cmc and labeling
About
Experienced Regulatory Affairs Specialist with a demonstrated history of working in the pharmaceuticals industry. Skilled in eCTD, GMP practices, Good Laboratory Practices (GLP), Abbreviated New Drug Application (ANDA) submissions, Biopharmaceuticals, Regulatory Requirements, and Adobe Acrobat. Detail-oriented, organized, and enthusiastic graduate of biochemistry with a passion for medicine and healthcare.
united states
raleigh
pharmaceuticals
leadership, pharmaceutical industry, regulatory affairs, regulatory submissions, microsoft office, microsoft word, social media, gmp, chemistry, drug development
Experience
member services
planet fitness
regulatory affairs associate, cmc and labeling
united therapeutics
organic chemistry lab associate
elmira college
regulatory affairs specialist
x-gen pharmaceuticals, inc.
* Duties of the Regulatory Affairs Specialist Includes: * Understand, interpret, and apply laws and regulations * Monitor and report new regulatory requirements * Advise companies on regulatory compliance * Prepare and manage regulatory submissions and communications with health authorities * Maintain regulatory files and ensure submission quality * Participate on product development teams to develop regulatory strategies * Assist on SOP development and review * Assist in monitoring project timelines
Education
elmira college
biochemistry
Presidential Scholarship Recipient (2011-2015) * Dean’s List (Fall 2011, Winter 2012, Spring 2012, Winter 2013, Spring 2014) * Phi Eta Sigma Freshman Honor Society (Fall 2011, Winter and Spring 2012) * Chemistry Club (2011-2015) * Pre-Health Club (2011-2015) * Beta Beta Beta National Biological Honor Society (2015) * Research project participant in the Chemistry Department (2014-2015) * Varsity Cheerleading Team (2011-2012) * Inaugural Women’s Cross Country Team (Fall 2014) * Courses completed: Biological Concepts I/II, Calculus I/II, Physics I/II, General Chemistry I/II, Comparative Anatomy, Statistical Methods, Organic Chemistry I/II, Microbiology, Analytical Chemistry, Biochemistry I/II, Genetics, Animal Physiology * Experienced with Word, Excel, Origin, PowerPoint, and Minitab
erica shepard's Contact Information
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