Scientist I, Quality Control LTS

Manager, UAT Analyst - Retail Operational Readiness Centre

Procurement Specialist

Supply Planning & Order Management Sr Specialist

Account Manager

Senior Software Engineer AI

Software Engineer AI

Commercial Finance Manager

Territory Sales Executive

Associate Director RA & QA

Role Description: <ul><li>The Scientist, Laboratory Technical Services is primarily responsible for supporting the analytical testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. </li><li>Has expert proficiency in conducting all types of physical and chemical analysis (including the most complex analysis) using all equipment. </li><li>This position will have a significant role supporting pending ANDA submissions, product launches, and method lifecycle activities to achieve company goals and initiatives. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Chemist.</li></ul> Responisbilities: Analysis &amp; Testing: <ul><li>Validate analytical methods for finished product and raw material release and stability testing.</li><li>Evaluates, troubleshoot/improves existing analytical methods when necessary.</li><li>Prepares method validation protocols, reports, and analytical test methods.</li><li>Performs testing to support process and formulation development (e.g. excipient, compatibility, solubility, dissolution studies, stability/impurity assessment)</li><li>Performs work to support project assigned with little oversight.</li><li>Presents analytical data to project team for review and discussion</li><li>Reviews and approves laboratory test data and documentation (e.g. notebooks, raw data and technical documentation, test methods, validation protocols, or validation report) for completeness and compliance when necessary</li><li>Reviews and evaluates drug substance supplier’s technical documents to ensure internal testing test requirements are adequate.</li><li>Uses laboratory software for analysis.</li><li>Is alert to and detects abnormalities during performances of test and reviews.</li></ul> Lab Equipment: <ul><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.</li><li>Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals</li><li>Troubleshoots instrumentation and performs subsequent analyses</li></ul> Investigations: <ul><li>Evaluates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action related to LTS activities</li><li>Participates in root cause identification of complex laboratory investigations.</li><li>Writes, edits, and reviews SOPs and laboratory investigations</li></ul> Training: <ul><li>Train junior Scientist/Chemists on analytical techniques.</li><li>Continuously updates knowledge with respect to the latest technologies related to analytical science</li><li>Maintains assigned training records current and in-compliance</li><li>Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures</li></ul> Compliance: <ul><li>Identifies need for SOPs and writes or revises, as appropriate</li><li>Performs work in a timely and safe manner conforming to regulatory, company and compendial requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations</li><li>Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs</li><li>Takes active role in auditing laboratory logbooks/documentation to ensure compliance</li><li>Follows internal processes related to controlled substances</li></ul> Safety: <ul><li>Follows EH&amp;S procedures to ensure a safe work environment</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS</li></ul> Requirements: Education &amp; Experience: <ul><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with 6 years’ relevant analytical laboratory experience OR</li><li>Master’s degree in above disciplines with 4 years’ relevant analytical lab experience OR</li><li>PhD in above disciplines with some relevant analytical laboratory experience preferred</li></ul> Knowledge &amp; Skills: <ul><li>Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports.</li><li>Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.</li><li>Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS</li><li>Has demonstrated competence in conducting chemical analyses</li><li>Strong knowledge of wet chemistry techniques</li><li>Competency in Microsoft Office Suite</li><li>Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information</li><li>Ability to display and analyze data in a logical manner</li><li>Strong verbal and written communication skills as well as good computer skills</li><li>Strong attention to details and accurate record keeping</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills</li><li>Ability to coach less senior staff and develop laboratory skills and ability</li><li>Ability to take initiative, set priorities and follow through on assignments</li></ul> Physical Requirements: <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Responsibilities: <ul><li>Understand Business Requirements and Functional Specs/ User Story documents</li><li>Prepare Test Case Design using TOSCA or other Bank approved tools for the technology change</li><li>Ensure traceability for requirements/ functional specs to test cases</li><li>Engage business/ operations users to review test cases and incorporate their feedback into test pack</li><li>Identify potential scenarios for Test Automation working with the Automation Lead</li><li>Drive Manual &amp; Automated Test Execution (using TOSCA/ other Bank Approved tool) as per the UAT Plan in line with the test strategy and test plan</li><li>Ensure all test scope and test cases are executed and fulfil the specified requirements within the agreed timeline</li><li>Report defects discovered in UAT, attend defect calls and participate in defect management process and retest</li><li>Review UAT test results and publish test metrics</li><li>Perform Exploratory Test Case execution</li><li>Provide operational readiness support and conduct training on new system/ enhancement to impacted operations and/ or business users</li><li>Provide post-implementation support to operations users</li><li>Review and submit management reports as required by the Bank’s Software Development Framework</li></ul> Requirements: <ul><li>Bachelor’s degree</li><li>Minimum 4 years of experience preferably in financial institutions</li><li>Well-versed in operations especially Swift standard in either AS400 / Mainframe applications, Internet / Mobile Banking Application, Cards and Channels application will be an added advantage</li><li>Have a good knowledge and experience in handling testing or test management life cycle</li><li>Proficient computer skills</li><li>Strong analytical skills</li><li>Strong verbal and written communications skills, including effective presentation skills</li><li>Able to take ownership of issues and take them to closure</li><li>Able to create effective work relationships across different levels of stakeholders from various disciplines</li><li>Experience in managing team</li><li>Motivated driven and can work under pressure and able to complete task given within the project timeline</li><li>Mature individual with strong leadership, influencing and problem resolution skills</li><li>Lead human resource planning, development and staff management</li></ul>

Role Description: <ul><li>The Procurement Specialist is responsible for managing the procurement of direct and indirect materials and services to ensure uninterrupted supply to manufacturing operations while achieving cost, quality, delivery, and working capital objectives. </li><li>The role partners closely with Production Planning, Operations, Quality, Finance, and Global Procurement to execute sourcing strategies, manage supplier performance, and support continuous improvement initiatives across the supply chain.&nbsp;</li><li>The successful candidate will have strong procurement execution skills, supplier management experience, and a proactive approach to resolving supply risks and driving operational excellence.&nbsp;</li></ul> Responsibilities: Procurement &amp; Supply Management&nbsp; <ul><li>Execute procurement activities for assigned direct materials, packaging materials, indirect spend categories, and services.</li><li>Convert purchase requisitions into purchase orders and manage end-to-end procurement transactions within SAP.</li><li>Ensure material availability to support production plans and customer commitments.</li><li>Monitor supplier delivery performance and proactively manage supply risks.</li><li>Coordinate with planning and operations teams to address shortages, delays, and capacity constraints.</li><li>Maintain optimal inventory levels in line with working capital and service objectives.&nbsp;</li></ul> Supplier Management&nbsp; <ul><li>Manage day-to-day supplier relationships and performance.</li><li>Monitor supplier KPIs including:&nbsp;&nbsp;On-Time Delivery (OTD), Quality performance, Lead time adherence, Responsiveness&nbsp;, Cost competitiveness</li><li>Conduct supplier performance reviews and support corrective action implementation where required.&nbsp;</li><li>Escalate supply risks and develop mitigation plans to ensure business continuity.</li></ul> Cost &amp; Contract Management <ul><li>Support sourcing initiatives and cost reduction projects.</li><li>Obtain quotations and conduct commercial evaluations.</li><li>Participate in supplier negotiations under guidance from Global Procurement or Supply Chain leadership.</li><li>Support implementation of payment term optimization initiatives.</li><li>Ensure contract pricing and procurement terms are accurately maintained within systems.&nbsp;&nbsp;</li></ul> Inventory &amp; Working Capital Management&nbsp; <ul><li>Collaborate with planning teams to optimize inventory levels.</li><li>Identify excess, obsolete, and slow-moving inventory risks.</li><li>Support inventory reduction initiatives without compromising customer service.</li><li>Monitor supplier lead times and MOQ impacts on inventory performance.</li></ul> SAP &amp; Process Excellence&nbsp; <ul><li>Maintain accurate procurement master data including:&nbsp;&nbsp;Vendor records, Pricing information, Lead times, Procurement parameters&nbsp;</li><li>Support SAP implementation and continuous process standardization initiatives.</li><li>Ensure compliance with procurement policies, approval authorities, and audit requirements.</li><li>Drive continuous improvement opportunities in procurement processes and supplier collaboration.</li></ul> Requirements:&nbsp; <ul><li>Bachelors Degree in Supply Chain Management, Procurement, Business Administration, Engineering, or related discipline.</li><li>3–7 years of procurement, purchasing, materials management, or supply chain experience.</li><li>Experience in manufacturing environments preferred.</li><li>Experience working with international suppliers and supply networks.</li><li>SAP ERP experience preferred.</li><li>Experience supporting sourcing, supplier management, and inventory optimization initiatives.</li><li>Experience in procurement or supply chain within a manufacturing environment.</li><li>Good understanding of supplier management, inventory control, and material planning (MRP).</li><li>Proficiency in SAP and Microsoft Excel for procurement and data analysis.</li><li>Strong communication, negotiation, and problem-solving skills.</li><li>Ability to collaborate effectively with cross-functional teams and suppliers.</li><li>Experience supporting cost-saving, process improvement, or SAP implementation initiatives.&nbsp;&nbsp;</li></ul>&nbsp;&nbsp;

Responsibilities: Order Management &amp; Fulfilment Execution <ul><li>Manage end-to-end order intake to fulfilment process ensuring alignment with customer requirements and supply capabilities.</li><li>Monitor and manage order backlog, ensuring timely resolution of constraints and prioritization.</li><li>Coordinate closely with Customer Support / Commercial teams on demand fulfilment and order commitments.</li><li>Drive proactive communication on order status, delays, and recovery plans.</li></ul> Supply Planning &amp; Prioritization <ul><li>Collaborate with Production Planners to translate demand into executable production and fulfilment plans.</li><li>Lead order prioritization decisions based on customer criticality, contractual commitments, and business impact.</li><li>Ensure optimal allocation of constrained supply across customers and regions.</li><li>Support escalation management for supply-demand imbalances.</li></ul> Capacity Planning &amp; RCCP <ul><li>Develop and maintain Rough-Cut Capacity Planning (RCCP) to ensure alignment between demand and production capacity.</li><li>Identify capacity constraints early and drive mitigation actions (e.g., alternate sourcing, schedule optimization, subcontracting).</li><li>Partner with manufacturing and procurement teams to balance load vs. capacity.</li></ul> Customer Stock Build &amp; Inventory Coordination <ul><li>Manage customer-specific stock build strategies to support service level targets and campaign demand.</li><li>Coordinate with inventory and warehouse teams to ensure optimal stock positioning Monitor and control inventory risks (excess, slow-moving, or shortages) linked to customer demand patterns.</li></ul> Cross-Functional Coordination (Control Tower Role) Act as the central coordination point between: <ul><li>Commercial / Demand Planning.</li><li>Customer Service o Production Planning.</li><li>Procurement / Logistics o Global Supply Chain team.</li><li>Drive alignment on order fulfilment strategies and execution plans.</li><li>Lead regular order fulfilment reviews and backlog governance meetings.</li><li>Performance Monitoring &amp; Continuous Improvement.</li></ul> Track and report key KPIs: <ul><li>OTIF (On-Time In-Full).</li><li>Backlog aging.</li><li>Service level adherence.</li><li>Capacity utilization.</li></ul> Identify root causes of service failures and drive corrective actions Lead or support initiatives to improve: <ul><li>Order cycle time.</li><li>Planning accuracy.</li><li>Supply chain responsiveness.</li></ul> Requirements: <ul><li>﻿Bachelors Degree in Supply Chain Management, Procurement, Business Administration, Engineering, or related discipline. </li><li>3–7 years of procurement, purchasing, materials management, or supply chain experience.</li><li>Experience in manufacturing environments preferred. </li><li>Experience working with international suppliers and supply networks.</li><li>SAP ERP experience preferred.</li><li>Experience supporting sourcing, supplier management, and inventory optimization initiatives.&nbsp;</li></ul>

&nbsp;Reponsibilities: <ul><li>Drive HVAC/HVACR sales growth by managing key customer accounts, developing new business opportunities, and maintaining strong relationships with contractors, distributors, and end users across the Philippines market.</li><li>Promote our client cooling and refrigeration solutions through customer engagement, solution selling, project coordination, and regular site/client visits to build a strong sales pipeline.</li><li>Collaborate with internal teams to support quotations, project follow-ups, and customer requirements while achieving sales targets and business objectives.</li></ul> Requirements: <ul><li>Minimum 10 years of sales experience.</li><li>At least 3-5 years of experience in HVACR industry.</li><li>Candidate should have strong exposure to HVACR sales and customer management.</li></ul>

Responsibilities: Design &amp; Build/Development &amp; Support <ul><li>Develop multi-agent workflow automation patterns using Agentic AI</li><li>Process redesign and mapping to agentic workflow patterns</li><li>Architect scalable micro-services that wrap LLM/RAG/Agent workflows (Python).</li><li>Implement robust prompt-engineering patterns, retrieval pipelines, and caching for AI Assistants and AI Agents</li><li>Profile inference latency, GPU/CPU utilization, and memory</li><li>Writes and maintains highly complex unit tests and integration tests, and performs debugging to maintain the quality and performance of the software/AI solutions</li><li>Lead bug-fix, security-patch, and performance-tuning sprints for live AI Assistants and AI Agents</li><li>Leads the establishment and maintenance of comprehensive documentation for agents, applications, deployment processes and system configurations.</li></ul> Operational Excellence&nbsp;<ul><li>Own on-call runbooks, SLOs, and incident reviews; embed observability</li><li>Leads and mentors technical support and troubleshooting for highly complex issues with deployed applications to ensure minimal downtime and fast resolution.&nbsp;</li></ul> Collaboration &amp; Leadership <ul><li>Leads cross functional team of engineers to gather requirements and deliver solutions that meet business needs.</li><li>Experience working within product and agile delivery frameworks including backlog management and cross-functionality delivery and full E2E engineering.&nbsp;</li><li>Experience with enterprise architecture, data governance, or security standards in the context of digital solution delivery as part of E2E engineering and solution architecture.&nbsp;</li></ul> Capability &amp; Technology Stack Exposure <ul><li>Experience with digital technologies in the commercial &amp; sales management capability (e.g. Salesforce, Service Cloud, CPQ, Salesloft, ChatGPT or similar platforms)&nbsp;</li></ul> Requirements: <ul><li>Minimum requirement of 4 years of relevant work experience. Typically reflects 5 years or more of relevant experience.&nbsp;</li><li>Typically reflects 4 years or more with 3+ years of cloud-native AI/ML or GenAI systems (Azure, AWS, or GCP) or 2+ years of software development.&nbsp;</li></ul>

Responsibilities: Design &amp; Build/Development &amp; Support <ul><li>Develop multi-agent workflow automation patterns using Agentic AI</li><li>Process redesign and mapping to agentic workflow patterns</li><li>Architect scalable micro-services that wrap LLM/RAG/Agent workflows (Python).</li><li>Implement robust prompt-engineering patterns, retrieval pipelines, and caching for AI Assistants and AI Agents</li><li>Profile inference latency, GPU/CPU utilization, and memory</li><li>Writes and maintains highly complex unit tests and integration tests, and performs debugging to maintain the quality and performance of the software/AI solutions</li><li>Lead bug-fix, security-patch, and performance-tuning sprints for live AI Assistants and AI Agents</li><li>Leads the establishment and maintenance of comprehensive documentation for agents, applications, deployment processes and system configurations.</li></ul> Operational Excellence&nbsp;<ul><li>Own on-call runbooks, SLOs, and incident reviews; embed observability</li><li>Leads and mentors technical support and troubleshooting for highly complex issues with deployed applications to ensure minimal downtime and fast resolution.&nbsp;</li></ul> Collaboration &amp; Leadership <ul><li>Leads cross functional team of engineers to gather requirements and deliver solutions that meet business needs.</li><li>Experience working within product and agile delivery frameworks including backlog management and cross-functionality delivery and full E2E engineering.&nbsp;</li><li>Experience with enterprise architecture, data governance, or security standards in the context of digital solution delivery as part of E2E engineering and solution architecture.&nbsp;</li></ul> Capability &amp; Technology Stack Exposure <ul><li>Experience with digital technologies in the commercial &amp; sales management capability (e.g. Salesforce, Service Cloud, CPQ, Salesloft, ChatGPT or similar platforms)&nbsp;</li></ul> Requirements: <ul><li>Minimum requirement of 2 years of building production software or data platforms.&nbsp;</li><li>Typically reflects 3 years or more with 2+ years of cloud-native AI/ML or GenAI systems (Azure, AWS, or GCP) or 2+ years of software development.&nbsp;</li></ul>

Responsibilities: <ul><li>Own Managerial P&amp;L planning and forecasting, delivering accurate and documented forecasts and budgets</li><li>Lead and own the India FP&amp;A calendar (cross functional view – connected with S&amp;OP and Regional timeline)</li><li>Accountable for managerial P&amp;L reporting in Campari group consolidation system.</li><li>Provide visibility on P&amp;L by SKU / brand / state / channel / customer down to GP and/or CAAP and by account.</li><li>Manage SG&amp;A in collaboration with functional leaders.</li><li>Provide clarity on business performance drivers and variations vs previous forecasts, Budget and prior years</li><li>Pilar of the S&amp;OP process, leading the Volume to value conversion and ensure consistency with commercial planning.</li><li>Provide management relevant and accurate analytics providing visibility on the R&amp;O and as such, enabling effective business decisions.</li><li>Secure integrity of the Depletions/sell out reporting by brand, by state, by channel.</li><li>Understand COGS variances in collaboration with regional supply chain finance team</li><li>Work in close collaboration with controlling team to secure DD and A&amp;P accruals accuracy, documentation and relevance at all time.</li><li>Support Revenue Optimization agenda, partnering commercial team to optimize revenue performance by customers/distributors/channel and maximize profitability.</li><li>Drive internal control &amp; operating efficiency of the promotional program and trade spend.</li><li>Support Key Account managers for trade terms negotiation, providing relevant analytics.</li><li>Develop standardized Value Chain supporting commercial team needs</li><li>Develop sound and reasonable business case for innovation/new product launch/footprint expansion</li><li>Drive ROI analysis for all key initiatives – maximization of investment, share learnings.</li><li>Continually work with functional teams to drive profitable growth and strive for continuous ongoing improvement.</li><li>Drive initiatives through increased focus on the effectiveness and profitability of sales spend and through the proactive identification of profit/growth opportunities.</li><li>Represent finance and challenge financial efficacy in key cross functional forums like Exec reviews, valuation meetings.</li><li>Develop tools to support cross functional team work and decision making and help improvement of internal processes.</li><li>Support projects led by group aiming at improving analytics and efficiencies across finance</li></ul> Requirements: <ul><li>8-10 years experience in commercial finance and FP&amp;A role. Ideally close working experience with sales and marketing/ supply chain in a commercial capacity, preferably in the liquor industry or FMCG.</li><li>Qualification – Chartered Accountant</li><li>Experience in Liquor industry preferred, FMCG essential</li><li>Advanced excel and strong power-point skills</li><li>SAP, Power BI, BPC&nbsp;</li></ul>

Role Description: <ul><li>Seeking a technically strong and commercially driven Territory Sales Executive to support the execution of strategic account plans at a regional level across Southern Germany, Austria, and Switzerland.</li><li>This role focuses on activating distribution networks, influencing contractors, and ensuring successful deployment of solutions across enterprise customer branches.</li><li>Working closely with the Strategic Account Executive and Enterprise Account Team, you will act as the key link between headquarters strategy and on-the-ground execution across an extensive distributor and contractor network.</li></ul> Responsibilities: <ul><li>Execute the strategy defined by the Strategic Account Executive across assigned regional branches.</li><li>Develop and maintain strong relationships with local and regional distributors within the territory.</li><li>Coordinate closely with Enterprise Account Teams to ensure effective coverage of enterprise and large (Bracket I) accounts, including OEM centers.</li><li>Support and engage approximately 5 key wholesalers (HQ level) and their ~90 regional branches through training and activation initiatives.</li><li>Deliver product training and technical support across distributor branches and contractor networks.</li><li>Work directly with contractors as key influencers in the sales process, ensuring they are equipped to specify and promote solutions.</li><li>Implement channel strategies to drive revenue growth and increase market share through distribution partners.</li><li>Negotiate and manage local agreements, pricing structures, and performance metrics with distributors.</li><li>Conduct regular business reviews with partners to track performance and identify growth opportunities.</li><li>Ensure full alignment and communication between stakeholders across the value chain (HQ, branches, contractors).</li><li>Promote the full portfolio including compression, controls, and electronics as part of a 360° service offering.</li><li>Travel extensively within the assigned region.</li></ul> Requirements: <ul><li>Technical degree or apprenticeship in refrigeration engineering (mandatory: Mechatroniker für Kältetechnik or equivalent).</li><li>Minimum of 5 years’ experience in a technical sales, application engineering, or channel sales role.</li><li>Strong technical understanding of HVAC/R systems, including compressors, controls, and electronics.</li><li>Proven experience working with distributors, wholesalers, and contractor networks.</li><li>Excellent interpersonal and stakeholder management skills.</li><li>Ability to work autonomously while collaborating effectively within a matrix organization.</li><li>Native-level German language skills.</li><li>Strong proficiency in Salesforce or similar CRM systems.</li><li>High willingness to travel across Southern Germany, Austria, and Switzerland.</li></ul>

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>

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70 commercial banking Jobs found

Scientist I, Quality Control LTS

Manager, UAT Analyst - Retail Operational Readiness Centre

Procurement Specialist

Supply Planning & Order Management Sr Specialist

Account Manager

Senior Software Engineer AI

Software Engineer AI

Commercial Finance Manager

Territory Sales Executive

Associate Director RA & QA

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70 commercial banking Jobs found

Scientist I, Quality Control LTS

Manager, UAT Analyst - Retail Operational Readiness Centre

Procurement Specialist

Supply Planning & Order Management Sr Specialist

Account Manager

Senior Software Engineer AI

Software Engineer AI

Commercial Finance Manager

Territory Sales Executive

Associate Director RA & QA

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow is on a mission to connect companies with the best talent across the globe.