Regulatory Affairs - Operations and Data Manager, Asia

embecta; Johor Bahru; In loco; MYR 366.000 - 570.000; Tempo pieno

Descrizione del lavoro

embecta seeks an experienced Regulatory Operations Leader to manage Asia-Pacific regulatory activities, data integrity, and cross-functional coordination to support market access.

The role combines RA expertise with data analytics, project management, and stakeholder engagement across regional and global teams to drive timely approvals and compliant operations.

Competenze

• Bachelor's degree in Regulatory Affairs, Life Sciences or related field.
• Minimum 7 years of regulatory affairs and regulatory operations experience in medical devices or related sectors.
• Experience across Asia-Pacific or Emerging Asia markets is preferred.
• Strong MS Excel and data analytics skills; familiarity with regulatory data management systems.

Mansioni

• Coordinate product registrations, submissions, renewals, and amendments across Asia markets.
• Maintain country-level assessments for ~20 Asia markets and ensure documentation needs are met.
• Prepare and manage regulatory dossiers, FSCs/FGs, legalisations, and related technical docs.
• Oversee product lifecycle changes, labelling updates, and regulatory impact assessments.
• Monitor regulatory developments via Medboard and other sources; communicate implications.
• Support advertising reviews, market access activities, and regulatory information requests.

Conoscenze

Regulatory affairs

Data analytics

Project management

Stakeholder engagement

Power BI

Excel

Formazione

Bachelor's degree in Regulatory Affairs or Life Sciences

Strumenti

Power BI

Ariba

Freshservice

eRIM

Descrizione del lavoro

Serves as the primary point of contact for Regulatory Operations in Asia, providing regulatory, operational, data management, and administrative support to Asia Regulatory Affairs teams to facilitate timely product registrations, regulatory approvals, ongoing compliance, and market access objectives.

Combines hands-on Regulatory Affairs expertise with strong data analytics, project management, and stakeholder engagement to monitor and drive regulatory activities across Asia markets. Working across dual reporting lines to Asia Regulatory Affairs and International Regulatory Operations leadership, the role manages priorities, drives accountability, identifies risks, and improves regulatory processes and operational performance.

RESPONSIBILITIES:

Regulatory Affairs and Market Execution

• Product Registrations and Submissions: Coordinate and drive product registrations, submissions, renewals, and amendments across Asia markets. Ensure RA colleagues have detailed registration plans, monitor milestones and outstanding actions, navigate internal processes, resolve issues, and escal ate risks to support timely approvals.
• Country-Level Assessments: Coordinate and maintain country-level assessments (CLAs) for approximately 20 Asia markets, ensuring accurate regulatory requirements, registration pathways, and documentation needs.
• Regulatory Documentation: Coordinate the preparation and collection of registration dossiers, Certificates of Free Sale (FSCs), Free Goods Certificates (FGs), legalizations, and supporting technical documentation from internal stakeholders, global teams, and external partners. Support regulatory authority queries and information requests.
• Product Lifecycle Management: Coordinate renewals, change notifications, registration amendments, labelling updates, and regulatory impact assessments to maintain compliance and market access.
• Regulatory Intelligence (Medboard): Monitor regulatory developments through Medboard and other relevant sources, assess impacts on Asia markets, communicate relevant changes, and coordinate follow-up actions.
• Advertising, Promotion and Market Support: Serve as the Asia Regulatory Affairs point of contact for advertising and promotional activities, coordinating regulatory reviews of promotional materials, product claims, and local labelling. Support regulatory information requests, tenders, and commercial activities as required.

International Regulatory Operations and Data Management

• Registration Tracking (IRT): Maintain and update the Integrated Registration Tracker (IRT), ensuring accurate tracking of regulatory submissions, approvals, renewals, registration milestones, risks, and outstanding actions across Asia markets.
• eRIM and Regulatory Data Management: Maintain accurate country-level registration and licence records, SKU mapping, change and impact assessments, regulatory memos, and supporting documentation in eRIM, ensuring data integrity, completeness, and consistency.
• Regulatory Reporting and Power BI: Prepare weekly operational reports, monthly Asia status and registration reports, KPI dashboards, and management summaries. Maintain and enhance Power BI dashboards to identify trends, delays, risks, and opportunities for improvement.
• Freshservice RA Ticket Management: Manage Freshservice RA ticket workflows, including rollout, triaging, prioritization, troubleshooting, customer support, and timely responses. Maintain dashboards and analytics, monitor performance, and drive improvements in ticket resolution and service delivery.
• Global Trade Services (GTS): Coordinate regulatory assessments and resolution of GTS blocks, product release requests with relevant cross-functional teams.
• Regulatory Systems and Process Improvement: Drive improvements to regulatory workflows, data management, tracking systems, and reporting. Support SOP development and maintenance, system enhancements, and implementation of best practices to improve operational efficiency.

Stakeholder Management and Delivery

• Dual Reporting and Stakeholder Management: Manage priorities and expectations across Asia Regulatory Affairs and International Regulatory Operations leadership. Build strong relationships, influence, and drive cross-functional commitments to completion.
• Project Management and Risk Escalation: Manage assigned regulatory projects and operational initiatives, tracking deliverables, timelines, dependencies, and risks. Proactively address delays, coordinate corrective actions, and elevate issues with recommended solutions.
• Operational Coordination and Support: Serve as the primary point of contact for Regulatory Operations in Asia, coordinating activities with regional, International and global teams, distributors, consultants, and vendors. Provide operational and administrative support to Asia Regulatory Affairs teams, including vendor coordination and Ariba purchase orders, to facilitate timely regulatory approvals and market access objectives.
• Compliance, Governance and Representation: Support regulatory compliance, audit readiness, and maintenance of accurate regulatory records in accordance with company quality standards. Represent Asia Regulatory Affairs and Operations in relevant forums, meetings, and training activities.

EXPERIENCE & EDUCATION:

• Bachelor's degree in Engineering, Information Technology, Life Sciences, Pharmacy, Regulatory Affairs, Chemistry, Biology, Toxicology, Pharmacology, Health Sciences, Clinical Sciences, or a related discipline.
• Minimum 7 years of relevant experience in the medical device industry, including hands-on Regulatory Affairs experience in submission preparation, product registrations, renewals, and lifecycle management, together with Regulatory Operations experience.
• Experience supporting regulatory activities across multiple Asia-Pacific or Emerging Asia markets is preferred.
• Strong experience in regulatory operations, data management, registration tracking, reporting, and regulatory information management systems.
• Demonstrated project management and stakeholder management experience, with the ability to coordinate cross-functional teams, influence without direct authority, and drive deliverables to completion.
• Strong Microsoft Excel and data analytics capabilities; experience with Power BI, eRIM, Freshservice, or similar regulatory systems is advantageous.
• Excellent written and spoken English. Experience working within a multinational medical device organization and with geographically dispersed teams is preferred.

KNOWLEDGE, SKILLS AND ABILITIES:

• Regulatory Knowledge and Judgement: Strong understanding of medical device regulatory requirements, submission processes, product lifecycle management, and compliance. Ability to assess regulatory issues and exercise sound judgement under pressure. Knowledge of ASEAN and Emerging Asia regulations is preferred.
• Data Management and Analytics: Strong analytical skills, including regulatory data management, KPI reporting, and the development and enhancement of dashboards and data tools, particularly Power BI.
• Stakeholder and Expectation Management: Excellent interpersonal, negotiation, and influencing skills, with the ability to manage stakeholder expectations, balance competing priorities, and maintain professionalism across functions and reporting lines.
• Project Management and Execution: Strong planning, organizational, and document management skills, with the ability to manage multiple projects, meet deadlines, monitor deliverables, and drive activities to completion.
• Communication and Collaboration: Excellent written and spoken English, with strong communication, teamwork, and customer-focused skills. Ability to work effectively across cultures, engage senior stakeholders, and represent Regulatory Affairs in cross-functional forums and committees.
• Digital Tools and Operational Systems: Advanced proficiency in Microsoft Office, particularly Excel, and experience with regulatory information management systems, electronic document management systems, databases, and workflow tools. Familiarity with regulatory vendor management, purchase orders, and Ariba is advantageous.
• Problem Solving, Quality and Accountability: Proactive, solutions-oriented, and detail-focused, with strong problem solving skills, sound judgement, and the ability to work independently, take ownership, and maintain high standards of accuracy and compliance.
• Process Improvement and Adaptability: Ability to develop and improve regulatory processes, support SOP development and revisions, implement best practices, and adapt to changing priorities and additional projects with a positive, can-do attitude.