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: Responsible for formatting and publishing electronic documents, and building of regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs and their amendments and supplements in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
Electronically format, publish electronic documents and builds Regulatory submission deliverables and ensures quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures.
Provides guidance on good documentation and submission practices
Assist with developing and maintaining Regulatory document processing and Regulatory submission publishing standards and procedures
Identifies and communicates regulatory system enhancement needs or technical issues
Assists with regulatory inspection activities
Collaborates with vendors who support Regulatory operations related tasks.
Communicates the need for additional resources to management as needed.
Provides support and backup to management as needed.
May be responsible for supervising staff. Requirements:
Requires strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc)
Advanced knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems, document authoring templates, document publishing tools, publishing systems, eCTD validation and viewing tools and XML are required.
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. Associated topics: clinical, dietetic, disease, health, histology, industrial hygienist, medical, microbiology, patient, pharmacology
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.