Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health. We are seeking a highly skilled and experienced Regulatory Publishing Specialist to join our dynamic team. The ideal candidate will have a strong background in formatting and publishing electronic documents, and building of regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs and JNDAs and their amendments and supplements in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, JP, ICH, etc). In this role typical day might include performing the following: Electronically format and publish submission components in line with regional specifications. Compile and validate electronic submissions in publishing software (Lorenz Docubridge) Accountable for dispatching finalized submissions through the appropriate regulatory authority portal and archiving in Veeva. Responsible for overseeing routine submissions, including the creation of submissions in Veeva. Provides mentorship 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 improvement needs or technical issues. Assists with regulatory inspection activities. Collaborates with vendors who support Regulatory submission document related tasks. Provides support and backup to management as needed. This job might be for you if you: Bachelor s Degree with minimum of 2 years experience with Regulatory Operations Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). Strong 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. Familiarity with Veeva Vault Lorenz Docubridge would be helpful. Connect with us, so we can learn more about you, and you can learn more about our medicines. And join us in crafting the future of healthcare. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. Does this sound like youApply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Companys business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
