Experienced Regulatory Affairs Professional EMEA

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 .Job FunctionRegulatory Affairs GroupJob Sub FunctionRegulatory AffairsJob CategoryProfessionalAll Job Posting LocationsBeerse, Antwerp, Belgium; Leiden, South Holland, Netherlands; Madrid, Spain; Warsaw, Masovian, PolandJob DescriptionJanssen EMEA Neuroscience, Cardiovascular, Metabolic and Retina (NCMR) team is recruiting for an Experienced Regulatory Affairs Professional to work on the development and registration of NCMR products in Europe, the Middle East, and Africa (EMEA). The role supports small and large, advanced therapies across multiple disease areas.The successful applicant will help develop and implement regulatory strategies to achieve efficient development and timely commercialization of innovative pharmaceutical products in compliance with applicable regulations.Input in clinical development and post‑approvalSupport the EMEA Regulatory Liaison in developing the regulatory strategy for products in development and assist in submissions to health authorities from early development, CTAs to MAAs and life‑cycle management.Contribute to Global Regulatory Team meetings as the EMEA Regulatory ProfessionalGuide project teams on applicable regulatory requirements, contribute to regional and local regulatory strategy, and help address project‑specific regulatory issuesDevelop an understanding of the regional regulatory environment, competitor intelligence, and therapeutic areasLiaison with Regulatory Agencies and Local Operating CompaniesAct as backup for contact with EMA and national Regulatory AgenciesSupport the preparation of meetings with Regulatory AgenciesCollaborate with LOCs, track and respond to queries in a timely mannerInput in document and process developmentAssist in the creation and revision of processes related to regulatory submissionsDraft and review document content based on regulatory knowledgeContribute to and support the development of briefing documents, paediatric investigational plans, orphan drug designations, and response documents, where requiredProvide input to response documents to ensure they thoroughly and accurately answer the questions being posedTrack dates of regulatory agency submissions, questions, responses, and approvalsClinical Trial Applications – review protocols and ensure alignment with regulatory requirements; provide guidance to team on CTA submission strategies and documents; ensure CTA submission packages are complete according to agreed timelinesMarketing Authorization Applications – provide regulatory support throughout the life‑cycle of a product; guide and collaborate with cross‑functional teams on required documents and submission strategies in preparation for MAA; identify and supervise critical path activities; assist with timely submission and acceptance of MAA; ensure country‑specific submission packages are made available to the local operating companies (LOCs) in accordance with agreed plansJob RequirementsEducation and experienceBachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degreePreferred, or equivalent by experienceProven experience of 2+ years in regulatory affairs or other relevant functions.Experience working in cross‑functional teams.SkillsProject managementStrong oral & written communication skillsOrganization, prioritising, and multi‑tasking skillsKnowledgeKnowledge of the pharmaceutical regulatory environment, guidelines, and practice in EMEA, particularly the EU.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform critical job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.Johnson & Johnson is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.#J-18808-Ljbffr