Regulatory Publishing Specialist

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).

A typical day might include the following:

• Electronically formatting and publishing submission components in line with regional specifications.

• Compiling and validating electronic submissions using publishing software (Lorenz Docubridge)

• Dispatching finalized submissions through the appropriate regulatory authority portal and archiving in Veeva.

• Creating routine submissions including the creation of submissions in our EDMS (Veeva).

• Following standards andprocedures for Regulatory document and submissions processing.

• Identifying and communicating regulatory system enhancement needs or technicalissues.

• Assisting with regulatory inspectionactivities.

• Collaborating with vendors who support Regulatory submission document relatedtasks.

• Providing support and backup to management asneeded.

This job might be for you if you:

• Possess a Bachelors Degree and two years of relevant experience

• Have knowledge of applicable Regulatory Agency regulations guidelines and/or specifications (e.g. FDA EMA ICH etc..

• Have strong knowledge of Microsoft Word Adobe Acrobat electronic document management systems document authoring templates document publishing tools publishing systems eCTD validation and viewing tools and XML

• Have familiarity with Veeva Vault & Lorenz Docubridge

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 you Apply 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.