Senior Manager Workstream Lead

Senior Manager Workstream Lead – Regulatory 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 Function Regulatory Affairs Group Job Sub Function Regulatory Affairs Job Category Professional All Job Posting Locations North Ryde, New South Wales, Australia; Singapore Job Description Johnson & Johnson Ltd. is recruiting for a Senior Manager, Workstream Lead – Regulatory . This position is best based in J&J MedTech office in Singapore but open to other JNJ Offices in APAC. The role is accountable to define, harmonize, and deliver Global ERP capabilities design and deployment for APAC Regulatory business process scope while proactively highlighting and mitigating risks impacting delivery. Key Responsibilities Define the holistic business scope, including satellite system and cross‑workstream integrations. Evaluate inclusions/exclusions of new processes and prioritize backlogs. Identify gaps with the Global template and drive resolution to address those gaps. Accept/reject/reprioritize requirements using standard templates; escalt scope changes to PMO as needed. Translate business requirements into Business User Stories and partner with Technical teams to deliver systems solutions. Monitor solution build readiness, participate in demos, define mitigation plans and escalates risks to PMO. Lead Business Simulation Testing (BST), ensure comprehensive business scenarios, manage resources to meet test schedules, drive defect resolution and prioritization. Align on data cleansing scope and ownership; approve/reject changes to migration rules and scope; es... includes etc. Approve end‑user lists, position mappings, and role/security ownership. Ensure SOD conflicts are addressed; communicate organizational impacts and obtain business alignment. Support training strategy with Business Adoption Team. Define business cutover/hypercare strategies with Cutover Lead, align activities, owners, and timelines and serve as main contact for business owners within the workstream. Track hypercare metrics, identify deviations, and drive corrective actions. Collaborate with GPO, SME, IT, and PMO on planning and prioritization of any process design and build requirements. Use process design methodology, including relevant templates, tools, methodology, controls, and cadence to drive comprehensive solutions within the scope of the project. Drive definition, documentation, and alignment of capabilities across the key stakeholder groups. Review and approve end‑user business adoption mitigations for process changes. Deviations from Standard ERP or Template require leadership review and approvals. Partner with other functional teams to ensure a well‑rounded end‑to‑end solution. Partner with IT team to drive capabilities that are systematically crafted, built, validated, and deployed. Collaborate with master data team to ensure data configuration meets business capability needs. Partner with project management office to establish coordinated project plans/schedules/results. Partner with business adoption team to ensure organizational change, business readiness, site readiness, and training are delivered to meet business needs. Qualifications Education : Minimum of a bachelor’s degree. Required Experience and Skills Minimum 5 years of relevant experience in workstream, minimum 10 years overall business experience within associated functions: Plan, Source, Make, Quality, Deliver, Logistics, Regulatory or Analytics. Minimum 3 years of business process transformation, process design and optimization experience. Minimum 1 cycle of hands‑on ERP implementation experience in a sophisticated business and multi‑ERP/system environment. Experience in building consensus and ability to negotiate trade‑off decisions across the organization. Proven understanding of MedTech Supply Chain. Strong and tried project management experience. Strong customer focus (internal & external), including development and management of collaborators. Knowledge of deploying standardized work processes, tools, and templates. Exhibit strong communication and organizational change skills. Ability to build partnerships and collaborate both internally and externally. Exhibits outstanding business and digital competence. Exhibits initiative in innovative ways to challenges in a fast‑paced, changing global environment. Preferred An Advanced degree or MBA. Familiarity with GxP and SOX requirements and regulations as applicable for Workstream. Certification in areas of expertise (e.g., PMP, APICS, Lean/Six Sigma /Process Excellence, etc.). Other (Position requires up to 25% domestic and international) Required Skills Regulatory Inspections, Regulatory Negotiations, Regulatory Reporting, Regulatory Requirements, Regulatory Submissions Preferred Skills Analytical Reasoning, Business Writing, Fact‑Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Risk Compliance, Strategic Thinking, Technical Credibility #J-18808-Ljbffr