Associate Director RA & QA

Customer Service Specialist- Malaysia

Software Engineer, Quality Analyst

Lead Software Engineer, QA

Role Description: <ul><li>The Associate Director – Regulatory Affairs (CA) will lead the development and execution of regulatory strategies to support the timely approval, lifecycle management, and commercialization of generic pharmaceutical products in Canada. </li><li>The role will focus heavily on Abbreviated New Drug Submissions (ANDS) and Supplemental ANDS filings, while acting as the primary interface with Health Canada for regulatory discussions, clarifications, and negotiations.</li><li>This position plays a critical strategic role in new product development, portfolio expansion, and in-licensing evaluation, ensuring all regulatory activities align with Health Canada requirements, corporate objectives, and market access timelines.</li><li>The Director will also support portfolio maximization (PMX) initiatives, identify regulatory opportunities, and oversee a small regulatory team.</li></ul> Responsibilities: Regulatory Strategy &amp; Leadership <ul><li>Develop and implement regulatory strategies for ANDS submissions to Health Canada that maximize probability of approval and accelerate time to market.</li><li>Provide strategic regulatory guidance during product selection and development phases, including formulation, bioequivalence, and labeling strategy.</li><li>Ensure regulatory considerations are integrated into R&amp;D, clinical, CMC, and commercial planning.</li><li>Advise senior leadership on Canadian regulatory landscape, evolving guidelines, and approval pathways.</li><li>Lead regulatory planning for first-to-file, complex generics, and niche opportunities where applicable.</li></ul> Health Canada Engagement &amp; Regulatory Submissions <ul><li>Serve as the primary liaison with Health Canada, maintaining professional and proactive relationships with regulatory authorities.</li><li>Lead preparation and submission of: o Abbreviated New Drug Submissions (ANDS)</li><li>Supplemental ANDS (SANDS)</li><li>Notifiable Changes</li><li>Post-approval regulatory filings</li><li>Manage Health Canada deficiency responses, clarification requests, and review cycles.</li><li>Coordinate cross-functional teams to ensure high-quality regulatory dossiers</li><li>Represent the company in Health Canada meetings, scientific advice discussions, and regulatory negotiations.</li><li>Track and interpret Health Canada guidance updates, policy changes, and regulatory precedents affecting generic drug approvals.</li></ul> In-Licensing &amp; Regulatory Due Diligence <ul><li>Conduct regulatory due diligence for potential in-licensing and partnership opportunities.</li><li>Evaluation of regulatory pathways and submission feasibility</li><li>Data package completeness</li><li>Bioequivalence strategy</li><li>Intellectual property and exclusivity considerations</li><li>Estimated approval timelines and risks</li><li>Provide regulatory risk assessments and strategic recommendations to senior management during deal evaluation.</li><li>Support technology transfer and regulatory integration of licensed products into the company’s Canadian portfolio.</li></ul> Portfolio Management &amp; Lifecycle Optimization <ul><li>Support portfolio maximization (PMX) initiatives, including o Label expansions</li><li>New strengths and dosage forms</li><li>Site transfers</li><li>Manufacturing changes</li><li>Competitive lifecycle strategies</li><li>Identify regulatory opportunities to extend product lifecycle or improve market competitiveness.</li><li>Partner with commercial, market access, and supply chain teams to align regulatory activities with business objectives.</li></ul> Cross-Functional Collaboration <ul><li>Work closely with internal teams including o R&amp;D / Formulation Development</li><li>Clinical &amp; Bioequivalence</li><li>Quality Assurance / Quality Control</li><li>CMC / Manufacturing</li><li>Intellectual Property</li><li>Business Development</li><li>Provide regulatory input during product development milestones and technical reviews.</li><li>Ensure regulatory compliance with Health Canada, ICH, and global regulatory standards.</li></ul> Team Leadership &amp; Development <ul><li>Lead, mentor, and develop 1–3 regulatory associates/managers.</li><li>Oversee work allocation, submission timelines, and performance development.</li><li>Build a high-performance regulatory function capable of managing increasing submission volume.</li><li>Promote a culture of accountability, quality, and regulatory excellence.</li></ul> Requirements: Education &amp; Experience <ul><li>Advanced degrees in Pharmacy, Life Sciences, Pharmacology, Regulatory Affairs, or related discipline.</li><li>Regulatory certification (e.g., RAC) is considered an asset.</li><li>15–20 years of regulatory affairs experience within the pharmaceutical industry.</li><li>Extensive experience with Canadian regulatory submissions, particularly:</li><li>ANDS</li><li>SANDS</li><li>eCTD filings</li><li>Demonstrated experience interacting directly with Health Canada.</li><li>Strong understanding of Generic drug approval pathways</li><li>Bioequivalence requirements</li><li>CMC regulatory expectations</li><li>Experience supporting business development or in-licensing regulatory evaluations.</li><li>Previous team leadership or mentoring experience preferred.</li></ul> Core Competencies <ul><li>Strategic Thinking Ability to translate regulatory requirements into business-focused strategies that accelerate approvals and strengthen the company’s competitive position.</li><li>Regulatory Expertise Deep knowledge of Health Canada regulatory frameworks, ANDS requirements, and generic drug approval processes.</li><li>Stakeholder Influence Proven ability to engage effectively with regulatory authorities, internal leadership, and external partners</li><li>Physical Requirements</li></ul> Physical &amp; mental requirements: <ul><li>Business travel (15% of time), driving as part of work responsibilities.</li></ul>

Responsibilities: Quote and Order Management&nbsp; <ul><li>Interface with Customers for Quote request or Price inquiries and approval</li><li>Submit quotation request for pricing team approval.&nbsp;</li><li>Sales order entry, order confirmation &amp; expediting orders.</li><li>Order change and backlog price adjustment</li><li>On-going Backlog Management</li><li>Shipment release and follow up</li><li>Report and support past due backlog reduction</li><li>NPI - follow up with PM/Plant/Finance for part master and cost setup</li><li>Handle Sample order</li><li>Process RMA / Goods replacement</li></ul> Customer Service <ul><li>Handle customer enquiries &amp; complaints. Investigate and work with other departments to resolve customer issues in a timely manner.&nbsp;</li><li>Emails/Conference calls / Customer&nbsp;and company Plant Visits for critical delivery issues, expedition or projects.&nbsp;</li><li>Work out solutions on Customer’s special requirements, such as label, Customs process, packing &amp; etc.&nbsp;</li><li>NPS/VOC/Customer Service Survey Improvement Process. Identify and work on corrective actions to recurring issues.&nbsp;&nbsp;</li></ul> Customer Supply Chain Management&nbsp; <ul><li>Initiate Stock Requisition for customer advance order or buffer stock.</li><li>Work with Planning team on capacity adjustment in order to fulfill Customer’s demands</li><li>Consignment Stock Management/ Customer demand forecast monitoring and accuracy analysis</li><li>Manage customer forecast/demand and inventory level, work with Supply Chain to fulfill customer demand.&nbsp;</li><li>Negotiate with Customer for VMI liability and deadstock compensation.</li><li>Resolve logistics and custom issues with relevant functions</li></ul> Customer Credit and Billing Management <ul><li>Billing attainment</li><li>Follow up queries with Account Receivable</li><li>Coordinate with Finance and Customer to solve pass due invoices issue</li><li>Manage customer credit status &amp; escalate for any abnormal status</li><li>Apply credit release</li><li>Process Credit note / Debit Note</li></ul> Requirements: <ul><li>Bachelor’s degree is any related field.</li><li>Minimum 3 year of industry experience in customer service/order management.</li><li>Customer Focus.</li><li>Excellent communication skill. Able to interact with internal and external partners.</li><li>Problem solving skills</li><li>Team player with positive attitude.</li><li>Proactive, responsible and takes ownership of issues.</li><li>Able to work under pressure.</li><li>Self-motivated, independent and able to work with minimum supervision</li><li>Sense of urgency, analytical and able to multi-task under fast paced environment.</li></ul>

Responsibilities: <ul><li>Understand the test requirements and getting the team aligned with the same.&nbsp;</li><li>Participating on all technical aspects, interacting with client for all technical inputs and queries.&nbsp;</li><li>Automation and integration of complex processes.&nbsp;</li><li>Work closely with the development team on becoming the SME of the product.&nbsp;</li><li>Strong Testing Fundamentals , testing tools, reporting and frameworks.&nbsp;</li><li>Build and maintain the automation regression suite for the white box testing of the products.&nbsp;</li><li>Participate in requirement grooming and think form end customer perspective.&nbsp;</li><li>Should own all aspects of Testing, QA Framework for existing Products and Product end-to-end testing across functional, Security and Automation.&nbsp;</li><li>Work in a dynamic Agile environment and come up with solutions to meet project needs.&nbsp;</li><li>Communicate with Client and end customers in written and verbal.&nbsp;</li><li>Should be able to interact with client and customers for Escalated Customer Issues/Bugs.&nbsp;</li></ul> ﻿Requirements: <ul><li>Manual/Automation Testing - DataCom (Networking , Security, L2-L3, L4-L7 Protocols)&nbsp;</li><li>Hands on experience on Networking products Switch Router and Firewall&nbsp;</li><li>Good testing experience in Datacom/IP-Networking/Switching/routing domain.&nbsp;</li><li>Knowledge of Networking (L2/L3 protocols)&nbsp;</li><li>Knowledge of Testing tools : IXIA/SPIRENT&nbsp;</li><li>Security testing tool - Nessus, OpenVas, Achilles, Defensics (Anyone)&nbsp;</li><li>preferably knowledge / hands on in traffic generation tools such as IXIA or Spirent,&nbsp;</li><li>Performance and scalability testing, security, Penetration testing. packet sniffing tools.&nbsp;</li><li>Linux/containers Knowledge&nbsp;</li><li>Good understanding of testing concepts and hands-on experience in functional/sanity/regression testing.&nbsp;</li><li>CI/CD: Jenkins, GitHub, Bitbucket Actions&nbsp;</li><li>Scripting: Python and/or Shell is a must&nbsp;</li><li>Working experience in Routing protocols such as RIP, OSPF, BGP, MPLS VRRP&nbsp;</li><li>Good understanding of Management interface such as SNMP, Web, Yang, Netconf, Rest based interfaces etc&nbsp;</li><li>Good understanding of testing concepts and hands-on experience in functional/sanity/regression testing.</li><li>Strong written and oral communication skills.&nbsp;</li><li>High levels of motivation with a can-do attitude.&nbsp;</li></ul>

Role Description: <ul><li>Company’s Global R&amp;D team is looking for embedded software engineers and technical leaders to help build the future of industrial Automation &amp; Solutions.</li><li>You will have cross functional interactions and working closely with hardware, software, and product management teams.</li></ul> Responsibilities: As a Lead Software Engineer, the individual will work be in Embedded Software Development team. <ul><li>You provide the embedded platform infrastructure to enable our Industrial Networking Products.</li><li>You dedicate your creativity to a cross-functional, self-organized, agile team of developers.</li><li>You communicate with product owners, software architects and application developers in an intercultural and global work environment.</li><li>You contribute to the implementation of a Linux based Operating system for in-field embedded device families.</li><li>You assure the secure development life cycle of the platform and harden the attack surface of devices.</li><li>You will be part of the Software Platforms Teams, working on the development of in-house cybersecurity device software development for Industrial networks.</li><li>You will be building Firewall software for industrial routers which are complex multicore, multi-threaded software systems supporting high-availability, hundreds of network protocols and delivering high throughput packet forwarding.</li><li>Building brand new products, supporting new features, feature enhancements and sustenance of products across the R&amp;D product portfolio, using company’s device software running on company hardware.</li></ul> Requirements: <ul><li>You are a person with passion for coding and creating world class software systems for large organizations.</li><li>A Full time Bachelor/Master of Engineering Degree in Computer Science or equivalent.</li><li>You are able to abstract and use your creativity for disruptive solutions.</li><li>You are fluent in spoken and written English and have the ability or willingness to work in a Global environment</li><li>8 – 12 years’ experience in a product-based organization developing embedded software for Enterprise, Industrial Automation or Service Providers industry.</li><li>Solid understanding of embedded systems architecture, including microcontrollers, microprocessors, and real-time operating systems.</li><li>Ability to work on complex modular software systems, algorithms and be able to design, code, debug and automate software.</li><li>Expertise in C/C++ programming, data structures, Algorithms &amp; debugging tools.</li><li>Expertise in Linux based environment, with extensive knowledge of Linux Internals.</li><li>Hands-on operating systems, IPCs &amp; multi-thread programming experience.</li><li>Advanced working level knowledge of Computer networks and Network protocols in TCP/IP, switching (L2), routing (L3) &amp; security protocols.</li><li>One or more areas like QOS, Segment Routing, Multicast &amp; MPLS.</li><li>Ability to work with existing code base.</li><li>Hands-on experience in Versioning and Git/GitHub/Bitbucket repository.</li><li>Experience with Unit test strategy and execution.</li><li>Experience with Python or equivalent scripting languages</li><li>Experience with packet generating and network test tools.</li><li>Prior experience with any network OS provided by Networking companies like CISCO -IOS/IOS-XE/IOS-XR.</li><li>Designing &amp; understanding of network topologies &amp; deployment.</li><li>Linux containers and dockers.</li></ul>

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Associate Director RA & QA

Customer Service Specialist- Malaysia

Software Engineer, Quality Analyst

Lead Software Engineer, QA

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Associate Director RA & QA

Customer Service Specialist- Malaysia

Software Engineer, Quality Analyst

Lead Software Engineer, QA

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