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 **Experienced Regulatory Submissions** **Publishing** professional is responsible for executing the **electronic publishing of moderate to complex regulatory submissions for national, regional and global** regulatory agencies and operating companies in both **eCTD and non-eCTD format** . Responsibilities: + Utilizes regulatory information management systems and tools to assemble, publish, validate, dispatch and archive moderate-to-complex submissions according to internal processes and regulatory guidelines for paper and electronic submissions with a moderate 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 defines opportunities to streamline and align global submission processes, where possible, to enhance the overall submission workflow and quality of the published output. + Prioritizes submissions and special projects assigned with moderate level of independence and in communication with appropriate colleagues, as needed. Qualifications: + Ability to use Regulatory Information Systems, planning and /or publishing tools. + In-depth knowledge of and experience with various submission and application types, publishing templates and relevant regulatory agency and industry guidelines. + Skill to apply knowledge of submission-readiness and publishing standards. + Therapeutic area and product knowledge, strong 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. + Awareness of interdependencies and skill to collaborate cross-functionally to publish and dispatch compliant submissions.