Nature and Scope The Regulatory Affairs Intern will support regulatory projects consistent with company goals by working closely with the hiring manager and cross-functional team members, including R&D, Manufacturing, Quality Assurance, Supply Chain, and PMO. The focus of the internship is for the intern to develop a deeper understanding of the drug development process and regulatory requirements in a professional work environment, while contributing to process optimization within the team. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Learn about the role of FDA in the drug development process for human and animal drugs. Gain hands-on experience in preparing regulatory documents for submission to the FDA. Learn about the different regulatory requirements for ANDAs, NDAs and NADAs. Learn about CMC technical product development and manufacturing functions in relation to regulatory affairs. Perform any other tasks/duties as assigned by management. Essential Functions of the Internship Responsible for assisting the regulatory team in the creation and maintenance of CMC and labeling submission content. Data review and remediation of CMC and labeling documentation. Uploading FDA Correspondence/FDA Questions/Commitments. Assist in Building Regulatory submissions in Docubridge. Exposure to Pharmacovigilance activities for pharmaceutical drugs. Contribute to Regulatory CMC process improvements. Support the drafting of CTD CMC sections to ensure on-time and high-quality applications for direct submission to FDA as needed. Provide support to Reg CMC team or hiring manager with Regulatory submissions and other tasks as needed. Perform any other tasks/duties as assigned by management. Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Students pursuing a degree in Science, Nursing, Healthcare, or Pharmacy. Students must have completed at least 3 years of college. Must be a well-organized self-starter that takes the initiative for independent work with attention to detail and has an ability to follow written & verbal instructions. Strong writing, communication, problem solving and interpersonal skills. Working knowledge of MS Word, MS Excel, Outlook, and Adobe Acrobat (Advanced Skills within Software a Plus). Ability to work overtime as needed. Physical Environment and Requirements While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools, or controls; reach with hands and arms; balance; talk and hear American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: American Regent Inc. endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com. American Regent, Inc.
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