Regulatory Information Management (RIM) Archivist
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases . Summary. Categorizes and classifies regulatory records related to regulatory applications, maintains regulatory application indexes, scans paper documents and uploads into the Regulatory Document Managemetn System, and assists with managing paper archives, audit and inspection activities and user training. This position will report to the RIM director . Responsibilities - Archives categorizing and classifying information all Regulatory records pertaining to multiple Regulatory Applications INDs, BLAs, etc , maintaining Regulatory application indexes, tracking of regulatory documents, and assisting with special projects as needed - Maintains all electronic and paper archives for all Regulatory submissions, submission documents, and any related correspondence for multiple Regulatory Applications INDs, BLAs, etc - With some guidance, maintains and ensures Regulatory information is accurate in Regulatory systems - Assists with reviewing and developing departmental procedural documents in accordance with Agency regulations and guidance - Scans paper documents into PDF format, OCR's the PDFs, and uploads the PDFs into the Regulatory Document Management System - Assists with audit and inspection activities including retrieval of Regulatory information - Participates in Regulatory Systems projects by assisting with system validation activities that support RIM processes - Supports archive projects such as migrating previously scanned paper submissions, legacy documents, and archive index information into the Regulatory EDMS - Assists with user training - Assists with managing paper archives - Assists with managing RIM knowledge objects - Identifies and communicates regulatory system enhancement needs or technical issues . Requirements - Bachelor's Degree preferred - 3-5+ Years - Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications eg, FDA, EMA, ICH, etc - Requires eCTD knowledge - Ability to categorize and classify information - Working knowledge of pharmaceutical metadata preferred - Can work independently some guidance from direct manager anticipated , ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills - Strong knowledge with Microsoft Word, Adobe Acrobat, and electronic document management systems are required - Provides support and backup to management as needed . This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business . To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid . Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.