Medline Industries has an immediate expansion opportunity for a Regulatory Affairs Specialist-Rotational Development located in the Northfield, IL headquarters. This position will primarily focus on regulatory affairs/compliance issues related to the wholesale distribution and manufacturing of healthcare products, including but not limited to pharmaceuticals and medical devices. This position will also provide opportunities to cross-train and work on special projects related to topics such as, regulatory operations, product labeling and marketing, new product development, premarket approval applications, and quality assurance. Excellent opportunity for professional growth and development of your healthcare regulatory affairs career with Medline by learning the skills required for a variety of regulatory affairs functional areas. We are seeking a dynamic, hardworking professional with a desire to work for a fast-paced, large corporate organization. In addition to exceptional leadership potential and analytical skills, you must have a roll-up your sleeves attitude. Responsibilities include: * Under general supervision, ensure the content, context, organization and overall quality of all regulatory documentation is adequate and sufficient to meet all regulatory requirements, commitments and agreements (labeling, licensing, registration, listing and/or submission for clearance or approval Medline facilities and/or product). * Review and approve promotional literature in paper or electronic format using information provided by product managers, vendors, divisional QAs, sales and marketing. * Review and approve product labeling using information provided by product managers, vendors, divisional QAs and marketing. * Complete and maintain Medline or vendor product licenses, registrations or listings as required, interacting with state, federal or international regulatory authorities and internal customers to accomplish. * Determine the requirements for and complete Medline product submissions for regulatory authority clearance or approval (to market a new product as a drug, medical device, food, dietary supplement, biological, cosmetic or commodity item) by working with vendors, internal customers and consultants as needed. * Communicate requirements of regulations to internal or external customers, or to vendors. * Initiate or maintain relevant procedures or SOPs, updating as needed and training when required. * Train new employees/product managers on labeling requirements as needed. * Conduct internal audits (files, processes, databases, etc.). * Assign NDC (National Drug Code) numbers, NHRIC (National Health Related Item Code) numbers, and any other standardized numbers as required. * Maintain department databases, logs and files. Requirements include: * Bachelors Degree (biology, chemistry, engineering, information technology, pharmacology, quality, toxicology, clinical sciences) AND at least 2 years of experience in regulatory, quality assurance, research and development/support, scientific affairs, operations, or related area preferred. OR * High school diploma or equivalent AND at least 5 years of experience in regulatory, quality assurance, research and development/support, scientific affairs, operations, or related area. * Experience applying an understanding of the current Regulatory environment and demonstrating the ability to perform within. * Experience applying knowledge of FDA regulations and guidelines on advertising and promotional drug products. * Experience evaluating information to determine compliance with standards, laws, and regulations. * Advanced skill level in SAP and AS400. * Advanced skill level in Excel, Word. Preferred requirements include: * At least 1 year of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. * Experience preparing and filing complete A/NDAs, Supplements, Amendments and Annual Reports to FDA. * Experience applying knowledge of the CFR, FDA/ICH guidelines and cGMPs as they pertain to pharmaceuticals. * Experience applying knowledge of FDA regulations and guidelines on advertising and promotional drug products.
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