The Manager Regulatory Publishing will be accountable for formatting and publishing electronic documents and building regulatory submission results such as INDs, CTAs, BLAs, MAAs & JNDAs, including their amendments and supplements, in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, PMDA, ICH, etc)
As a Manager Regulatory Publishing, a typical day might include the following:
Leads staff and/or vendors who electronically format, publish electronic documents and builds Regulatory submission results. Ensures quality, accuracy, and submission-readiness per Regulatory agency mentorship and specifications, and internal procedures.
Provides mentorship to multidisciplinary teams on developing submission structure strategies in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, PMDA ICH, etc)
Provides mentorship on good documentation and submission practices.
Assist with developing and maintaining Regulatory document processing and Regulatory submission publishing standards and procedures in accordance with all applicable Regulatory regulations, mentorship, and specifications.
Coordinate submission activities such as crafting and handling submission table of contents (TOCs) and supervising submission results. This also includes drafting cover letters for routine submissions and uploading submission documents to the regulatory submission document management system (RDMS)
Responsible for ensuring consistency and standardization to regulatory submissions across programs.
Provides mentorship to Reg Submission Management (Reg SM) team members and cross-functional groups to resolve issues related to submission schedules, documents readiness or other submission or regulatory-related requirements that could impact the timeliness or quality of submissions.
Liaises with Regulatory Publishing on publishing timelines and resourcing for major submissions and provides feedback to Regulatory Liaisons and Regulatory Project Management (Reg PM) on submission timelines and potential resource issues.
Provide training/mentoring to internal and external publishing staff. May assist and/or provide training to others on software tools used and educating authors on publishing policies and procedures.
Identify, assess, and actively resolve or bring up where vital any risks or issues that could impact the successful completion of regulatory submissions.
Assume the role of subject matter authority for specific functions or processes, interacting and mentoring both within the department and with external partners.
Evaluate activities and business processes, identify areas in need of improvement and take the lead in investigating potential solutions or new ways of working.
Responsible for global regulatory submissions/dossiers.
Performs day-to-day activities and results as it relates to publishing of submission-related documents for agency submissions.
Performs review and validation of submissions documents to ensure compliance with FDA, EMA, PMDA and ICH guidelines and internal standards for submission through e CTD format.
To Be Considered For This Role, You Must Have
Bachelor’s Degree or equivalent experience
8+ years of pharmaceutical experience
Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, PMDA, ICH, etc).
Sophisticated knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems, document authoring templates, document publishing tools, publishing systems, e CTD validation and viewing tools and XML are required.
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 Company's 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.