Job Description

Role Overview This is an entry-level regulatory affairs associate position. The candidate needs to have the ability to pay close attention to details, be proficient in Word and Excel, and have excellent writing and communication skills. Interpret and apply regulations. Primary Duties & Responsibilities Monitor and maintain current regulatory requirements and guidelines. Assist with the planning, writing and reviewing of regulatory documents including ad promo submissions, regulatory meeting documents, NDAs, annual reports, PADERs, amendments, and supplements to ensure high quality regulatory submissions. Assist with eCTD publishing of sequences. Manage and track labeling changes including drug registration and listing. Manage FDA correspondence including tracking logs of submissions and reports. Manage PO creation including setup of new vendors. Manage and coordinate timely renewals of state distribution licenses. Assist with miscellaneous regulatory-related administrative activities. Competencies/Career level Please list all that apply: Innovation, entrepreneurial attitude, customer orientation, team leadership, adaptability/flexibility, results-oriented, control of budgets/costs, Self-development. Requirements and personal skills Education: Bachelor of Science in Chemistry or Biology, PharmD preferred Languages: Fluent in English, proficiency in Spanish is desirable Experience (years/area): 1+ Specific Knowledge: Strong written and oral communication skills. Attention to detail, analytical, computer literacy, communication, problem-solving, and listening skills. Personal skills: Please list all that apply General management skills, strong interpersonal and people development skills, strong results-orientation, superior leadership skills, ability to anticipate problems and solve them Physical Demands Office-based (with some remote working per office policy), Monday to Friday, during official office hours. This role routinely uses standard office equipment such as computers, phones, printers, etc. Position Type and Expected Hours of Work: This is a full-time position. Days and hours of work are Monday through Friday, 9:00 a.m. to 5 p.m. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee: Is required to interact with internal and external contacts independently Is regularly required to talk or hear either in person, videoconference or over a dial tone phone, as well as a mobile phone, when applicable. Is often required to sit and occasionally to stand, walk, bend, or lift. Is required to occasionally lift office products and supplies, up to 40 Is desk-based and may be sitting for long periods of Must regularly use fingers and hands for fine manipulation: typing, writing, using hand-held device (iPad, laptop, cell phone, keyboard, printer) Must communicate clearly: video calls, phone calls, emails, in-person conversations Must possess ability to make sound decisions, process complex information, manage multiple tasks simultaneously, model behavior for other employees, and other cognitive Exeltis

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