Senior Manager Workstream Lead - Regulatory

Johnson & Johnson; Singapore; Hybrid; SGD 100,000 - 130,000; Full time

Job summary

A leading healthcare company is seeking a Senior Manager Workstream Lead - Regulatory to drive regulatory affairs initiatives in Singapore. The ideal candidate will have over 10 years of relevant experience, including business process optimization and ERP implementation. This hybrid role demands strong leadership and expertise in regulatory requirements. Join our team to make a profound impact on health for humanity.

Qualifications

• Minimum of 5 years of relevant experience in workstream.
• 10 years of overall business experience within associated functions.
• 3 years of business process transformation experience.

Responsibilities

• Define holistic business scope and evaluate new processes.
• Lead Business Simulation Testing and manage resources.
• Ensure SOD conflicts are addressed and communicate organizational impacts.

Skills

Regulatory Inspections

Regulatory Negotiations

Regulatory Reporting

Regulatory Requirements

Regulatory Submissions

Analytical Reasoning

Business Writing

Fact-Based Decision Making

Industry Analysis

Legal Support

Education

Bachelor’s degree

Job description

• Job title Senior Manager Workstream Lead - Regulatory
• Function Regulatory Affairs Group
• Sub function Regulatory Affairs
• Category Senior Manager, Regulatory Affairs (P8)
• Location Singapore / North Ryde / Singapore / Australia
• Date posted Nov 20 2025
• Requisition number R-045268
• Work pattern Hybrid Work

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

Key Responsibilities

• Define the holistic business scope, including satellite system and cross workstream integrations. Evaluate inclusions / exclusions of new processes and prioritization of backlogs.
• Identifying gaps with the Global template and driving resolution to address those gaps.
• Accept / reject / reprioritize requirements using standard templates; elevate 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 elevate 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; elevate migration risks.
• 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.
• Drives definition, documentation, and alignment of capabilities across the key stakeholder groups.
• Reviews and approves end user business adoption mitigations for process changes.
• Deviations from Standard ERP or Template, requires 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 meet business capability needs.

Qualifications and Experience

Education: Minimum of a bachelor’s degree.

Experience and Skills:

Required Experience

• Minimum of 5 years of relevant experience in workstream; minimum of 10 years of overall business experience within associated functions: Plan, Source, Make, Quality, Deliver, Logistics, Regulatory or Analytics.
• Minimum of 3 years of business process transformation, process design and optimization experience.
• Minimum of 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.

Required Skills

• Regulatory Inspections, Regulatory Negotiations, Regulatory Reporting, Regulatory Requirements, Regulatory Submissions

Preferred Experience

• 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.).

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

[Position requires up to 25% domestic and international]