At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Product Submissions and Registration **Job Category:** Professional **All Job Posting Locations:** Warsaw, Masovian, Poland **Job Description:** The **Senior Regulatory Submissions Publishing** professional is responsible for executing the electronic publishing of **complex regulatory submissions** for **national, regional and global** regulatory agencies and operating companies in both **eCTD and non-eCTD format.** + Proficient use of Regulatory Information Systems, planning, and/or publishing tools. + Expert level knowledge of and experience with various submission and application types, publishing templates and relevant regulatory agency and industry guidelines. + Project or submission management skills. + Therapeutic area and product knowledge, in-depth understanding of product development process. + Fluency in English; other languages may be required depending on assignment. + Ability to work or lead in a matrix environment. + Effective interpersonal, teamwork, networking, and communication skills. + Skill in collaborating across an organization to influence and develop work practices, standards and procedures. + Skill to coach and/or mentor colleagues in applicable guidelines, standards and publishing requirements. + Utilizes regulatory information management systems and tools to assemble, publish, validate, dispatch and archive complex submissions according to internal processes and regulatory guidelines for paper and electronic submissions with a high degree of independence. + Where appropriate, provides component-level publishing support for regulatory-owned deliverables in PDF format to ensure dossier components conform to submission standards (e.g., bookmarking, linking, PDF version, etc.). + Applies appropriate regulatory submission standards, requirements, processes, and policies to ensure compliance with applicable internal and external health agency guidelines. + Maintains open, timely, and effective communications with all publishing contributors and responsible regulatory affairs professionals to ensure timely delivery of submission components and/or complete submissions to release for dispatch to a health authority or distribution to a local operating company. + Proactively interacts and supports RA and cross-functional partners for submission-related needs and issues, as required. + Proactively provides technical training and/or guidance to submission contributors on submission requirements, standards, and processes to facilitate efficient processing by regulatory agencies. + Determines the scope of the electronic publishing requirements for the submission. + Identifies and drives business improvement opportunities to streamline and align global submission processes, where possible, across the organization, with a focus on quality, compliance and efficiencies. + Manages multiple high complexity submissions simultaneously with a high-degree of independence. + Interprets and enforces paper and electronic regulatory submission standards, policies, and operating procedure requirements. + Consults with various departments regarding submission requirements and standards to facilitate efficient processing by agencies. + Cultivates ongoing effective relationships within RA as well as cross-functionally. Works with partners to communicate and resolve issues/concerns with submission timelines.