Associate Director RA & QA

Senior Manager of Parts

Tax Lead

Technical Engineer, Mining

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>

Role Description:&nbsp; <ul><li>This person will be reporting to Aftersales Associate Director and will work daily with the Parts Distribution Manager.</li><li>The Senior Manager of Parts role is to develop and execute sales strategies, optimize pricing, build customer relationships, and drive revenue growth through spare parts sales on a national level.:</li></ul> Responsibilities: <ul><li>Develop and implement the national spare parts sales strategy, aligning it with the companys overall business goals and objectives.</li><li>Identify market opportunities, analyze customer needs, and devise strategies to maximize revenue generation from spare parts sales.</li><li>Collaborate with marketing teams and regional teams, to develop marketing campaigns and promotional activities to drive spare parts sales.</li><li>Provide leadership and oversight to the Parts Dealer Representatives team, ensuring strong dealer support, effective performance management, professional development, and resolution of escalated field and systemic parts-related issues in collaboration with supply chain and warehouse teams.</li><li>Work with finance to determine pricing strategies for spare parts based on market analysis, competitive landscape, and cost considerations.</li><li>Monitor price levels and margins to maximize profitability while remaining competitive in the market.</li><li>Analyze pricing trends and make adjustments as needed.</li><li>Build and maintain strong relationships with dealers. Identify customer needs, provide product information.</li><li>Conduct frequent dealer visits (up to 40% travel) US and Canada to address spare parts issues, promote parts sales, and drive optimal dealer stocking levels.</li><li>Collect and analyze sales data, market trends, and customer feedback to generate insights and reports.</li><li>Monitor sales performance against targets, identify areas for improvement, and develop action plans to enhance sales effectiveness.</li><li>Present reports and findings to senior management.</li></ul> Requirements: <ul><li>7–10 years of experience in sales, or aftersales in the agricultural machinery industry.</li><li>Proven experience working directly with dealers or in a dealership environment.</li><li>Proven track record of achieving sales targets and driving dealer network performance.</li><li>Strong mechanical aptitude with a comprehensive understanding of agricultural machinery, their applications, attachments, Implements.</li></ul>

Ovberview: <ul><li>We are seeking a highly skilled and detail-oriented Tax Analyst within our Global Business Services (GBS).</li><li>This role will contribute to the success of our global tax function by supervising day-to-day processing of tax related activities within the finance function.</li><li>The role will oversee senior and junior analysts who are responsible for analyzing complex tax data, supporting compliance, reporting and planning efforts.</li><li>The role will also be responsible for helping drive forward our strategic initiatives.</li><li>They will work closely with Supply Chain, Sales, Compliance, AR and AP Departments ensuring accuracy and timeliness in tax-related matters.</li></ul> Responsibilities: Tax Calculations: <ul><li>File annual income tax returns in accordance with country-specific regulations.</li><li>Submit monthly and quarterly sales tax filings and ensure timely compliance</li><li>Ensure appropriate accounting treatment in accordance with relevant standards</li></ul> Tax Strategy: <ul><li>Ensure maintenance of transfer pricing documentation and compliance with applicable laws</li><li>Optimize overall tax plan to achieve efficiency and compliance</li><li>Contribute to the development and implementation of tax planning strategies to minimize tax liabilities and ensure adherence to regulatory requirements</li><li>Ensure compliance with intercompany netting restrictions as required by organizational policies</li></ul> Tax Payments: <ul><li>Ensure compliance with country-specific tax payments, in close collaboration with AP Department (e.g. Brazil’s ICMS)&nbsp;</li><li>Oversee the customs payment process (e.g. Mexico’s Pago Electronico de Comercio Exterior (PECE) or Argentina’s Volante Electronico de Pago)</li><li>Review and register supplier-issued documents for compliance (e.g. Mexico’s Complemento de Pago, Constancia de Situacion Fiscal (CSF), Opinion Positiva SAT)</li></ul>&nbsp;Global Tax Support: <ul><li>Govern tax master data to ensure accuracy and completeness</li><li>Monitor ongoing tax compliance and remain current with changes in tax regulations</li><li>Address tax-related inquiries from internal and external stakeholders in a timely and professional manner</li><li>Conduct periodic audits of pay files for tax-related transactions to ensure accuracy and compliance</li></ul> Requirements: <ul><li>Bachelor’s degree in taxation, finance, accounting, Business Administration or a related field</li><li>5 - 10 years of relevant experience with tax accounting and general accounting</li><li>Ability to oversee group of tax analysts</li></ul>&nbsp;

Role Description: <ul><li>Your role is to maintain and grow Fluid technology Solutions sales in your sales sector.&nbsp;</li><li>Your experience means you are selling at all levels and grow our position as a leading, unique positive displacement pump types.</li><li>You will have a broad approach from sizing pumps at user level to keeping senior managers involved in new product introductions and purchasing groups commercially informed, requiring the overview, planning and approach of a manager.</li><li>Closeness to your markets will feedback into marketing strategy and tactics to develop our position further and therefore create new leads.</li></ul> Responsibilities: Sales &amp; Business Development: <ul><li>Maintain regular contact with customers to ensure Fluid Technology Solutions (WMFTS) products are specified in their operations.</li><li>Achieve and exceed sales targets by actively identifying and pursuing new business opportunities.</li><li>Increase market share by replacing competitor pump installations, including other peristaltic pump manufacturers and alternative pump technologies.</li><li>Develop proposals for transitioning clients to Bredel pumps through process optimization and de-bottlenecking.</li></ul> Customer &amp; Account Management: <ul><li>Manage and expand the spare parts and replacement pump business for existing clients.</li><li>Oversee spare parts and service programs for all delivered projects to ensure reliability and customer satisfaction.</li><li>Conduct regular on-site audits across target locations in Australia to secure ongoing spare parts and service contracts.</li><li>Build and maintain strong relationships with key personnel in Reliability, Process, and Maintenance across all sites.</li></ul> Sales Planning &amp; Reporting: <ul><li>Develop and execute structured call plans and visit cycles to ensure comprehensive coverage of existing and target accounts.</li><li>Maintain and update the CRM system with accurate customer data, interactions, and sales opportunities.</li><li>Keep the Sector Manager informed of competitor activity encountered in the marketplace.</li></ul> Customer Support &amp; Training: <ul><li>Arrange and conduct customer training sessions and presentations, both on-site and office-based, to enhance product knowledge and engagement.</li><li>Provide technical support to clients, offering solutions that optimize pump performance and overall system efficiency.</li><li>Quality &amp; Compliance</li><li>Conduct all activities in accordance with the company’s Quality Management System to ensure high standards of service and compliance.</li></ul> Requirements: <ul><li>Hands-on experience in mining.</li><li>Strong understanding of sales processes.</li><li>Product knowledge and application understanding.</li><li>Ability to sell solutions to mining companies.</li><li>Candidates from service background are also acceptable.</li><li>Experience in pre- and post-product services is required.</li></ul>

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4 canada de gomez Jobs found

Associate Director RA & QA

Senior Manager of Parts

Tax Lead

Technical Engineer, Mining

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Associate Director RA & QA

Senior Manager of Parts

Tax Lead

Technical Engineer, Mining

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

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TALENT

COMPANY

Contact Us

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