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:** People Leader **All Job Posting Locations:** High Wycombe, Buckinghamshire, United Kingdom **Job Description:** **About Innovative Medicine** Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a **Manager, RA Submissions, Knowledge Management** . This hybrid work position will be located in High Wycombe, United Kingdom Please note that this role is available across multiple countries and may be posted under different requisition numbers to follow local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s). + Poland; The Netherlands - Requisition Number: R-034275 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. The Knowledge Management and Process Excellence Lead is a strategic role responsible for designing and driving best-in-class knowledge management practices, optimising operational regulatory submission processes, and ensuring continuous improvement across the Next Gen Submissions organization. **Main Duties & Responsibilities:** ~50% of time: + Develop and maintain a structured knowledge management framework including governance, taxonomy, and content lifecycle. + Develop and maintain knowledge management technology platform. + Lead the creation, organization, and dissemination of regulatory submissions process documentation, SOPs, work instructions, and best practices. + Establish systems and tools for capturing institutional knowledge and regulatory submissions insights. + Create and oversee training materials and learning resources for Next Gen Submissions onboarding and upskilling. + Ensure version control and audit readiness for all process-related documentation. ~30% of time: + Analyse current workflows across Next Gen Submissions to identify bottlenecks, inefficiencies, and gaps. + Lead process mapping, standardisation, and optimisation efforts to drive operational efficiency and quality. + Implement Lean or Six Sigma methodologies to enhance effectiveness and ensure alignment with regulatory requirements. + Facilitate workshops to foster collaboration and promote a culture of continuous improvement. ~20% of time: + Partner closely with regulatory submission leads, quality, IT, and other stakeholders to harmonize processes and knowledge sharing. + Act as a change agent to drive adoption of new processes, tools, and systems. + Provide training, guidance, and mentorship to team members to build process excellence capabilities. + Support audit and inspection readiness through well-documented, standardised processes and accessible knowledge assets. **Qualifications** **Required:** + University/Bachelor’s degree and generally 6-8 years of overall experience. + Minimum 3 years in regulatory affairs/operations or quality systems + Experience mentoring or training peers + Experience with Regulatory Information Management (RIM) systems or Veeva Vault. + Experience supporting inspection readiness and compliance activities + Root Cause Analysis methodologies + CAPA systems, Regulatory Document Management/Publishing tools + Fluency in English, written and spoken **​Preferred:** + 5+ years of relevant industry experience. Masters/Pharm D /PhD + Advanced project management certification + Lean Six Sigma Black belt