Executive Assistant and Administrative Lead

Associate Director RA & QA

Tax Lead

Staff Quality & Reliability Engineer

Facility Mechanic

Machine Maintenance Technician

Responsibilities: Executive Support: <ul><li>Act as the primary point of contact for internal and external stakeholders on behalf of the MD.</li><li>Manage complex calendars, schedule meetings and appointments.</li><li>Prepare agendas, presentations, and reports for meetings.</li><li>Handle email correspondence and ensure timely responses.</li></ul> Travel Management: <ul><li>Liason with travel partner as SPOC for Travel Desk. Ensure timely wallet top up and accurate record-keeping. Manage Travel partner payment process and vendor management on SAP.</li><li>Arrange and coordinate domestic and international travel accommodations for the executives and others, including flight bookings, hotel accommodations, transportation, and itinerary planning.</li><li>Monitor travel itineraries, provide updates, and address any last-minute changes or emergencies.</li></ul> Confidentiality and Discretion: <ul><li>Handle sensitive and confidential information with intergrity, discretion and professionalism.</li><li>Maintain a high level of confidentiality in all aspects of the role.</li></ul> Compliance: <ul><li>Ensure 100% compliance on:&nbsp;</li><li>Vendor onboarding and documentation</li><li>Office safety protocols</li><li>Third-party office staff compliance</li><li>POSH training completion for all employees</li><li>Maintain accurate compliance records and provide periodic reports.</li></ul> Vendor Management: <ul><li>Oversee compliant and timely onboarding of vendors.</li><li>Supervise procurement quality assurance in SAP.</li><li>Ensure adherence to procurement policy from PO to Pay cycle.</li><li>Maintain accurate records for PO process, approvals, invoices, and agreements.</li></ul> Budgeting: <ul><li>Track monthly admin budget and ensure spend efficiency.&nbsp;</li><li>Provide 100% accurate monthly budget forecasting.&nbsp;</li><li>Monitor expenses and prepare reports for leadership review.</li></ul> Employee Engagement: <ul><li>Lead quarterly and annual R&amp;R programs, including trophy and certificate management.&nbsp;</li><li>Arrange and coordinate office events, meetings, and conferences, including logistics and catering arrangements.</li><li>Organize annual employee meets and engagement activities.&nbsp;</li><li>Ensure comprehensive onboarding for new joiners.</li></ul> Administrative Support &amp; Office Management: <ul><li>Oversee the general administrative functions of the office, handle administrative tasks including drafting correspondence, filing documents, and maintaining organizational systems.</li><li>Oversee the smooth operation of the corporate office, ensuring office supplies are stocked, equipment is maintained, and facilities are well-organized.&nbsp;</li><li>Ensure office operations run smoothly, maintaining a clean and well-organized workspace.</li><li>Help with ad-hoc tasks and projects as directed by the CXOs and corporate employees.</li><li>Serve as a liaison with building management vendor, external vendors, and service providers to address any office-related needs/issues.&nbsp;</li><li>Supervise office pantry and security staff</li></ul> Communication and Correspondence: <ul><li>Act as the primary point of contact between the CXOs and internal/external stakeholders.</li><li>Handle incoming and outgoing communications, including emails, phone calls, and mail.</li><li>Draft and proofread documents, reports, and presentations.</li><li>Draft and distribute internal and external communications, including announcements and reports for the CXOs</li><li>Coordinate and facilitate effective communication within the office.</li></ul> Requirements: <ul><li>5 years +&nbsp;</li><li>Global MNC experience is preferred.</li><li>Bachelors degree in business administration, management, or a related field (preferred).</li><li>Proven experience as both personal assistant and admin lead.</li><li>Excellent communication skills, both written and verbal, with the ability to interact professionally with individuals at all levels.</li><li>Strong attention to detail and accuracy in all work performed.</li><li>Strong organizational and multitasking abilities.</li><li>Arrange and coordinate office events, meetings, and conferences, including logistics and catering arrangements.</li><li>Understanding of 3rd Party Compliances.</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>

Responsibilities: Direct &amp; Indirect Tax Compliance <ul><li>Lead monthly, quarterly and annual compliance for corporate income tax, TDS/TCS, GST and other indirect taxes.</li><li>Oversee preparation and filing of income tax returns, GST returns and related statutory filings within timelines.</li><li>Ensure accuracy of tax provisioning, reconciliations and workpapers for statutory and internal reporting.</li><li>International Taxation</li></ul> Transfer Pricing <ul><li>Own transfer pricing policy and documentation (Master File, Local File), benchmarking studies and intercompany pricing reviews.</li><li>Manage TP audits, coordinate APAs/MAPs and defend positions before tax authorities.</li></ul> Audit, Assessments &amp; Dispute Management <ul><li>Manage tax audits/assessments, prepare responses and coordinate with external counsel/advisors.</li><li>Track litigations, maintain position papers, risk assessments and provisions as required.</li></ul> Advisory &amp; Controls <ul><li>Provide tax inputs for business initiatives, contracts, M&amp;A, restructurings and product pricing.</li><li>Implement and maintain tax policies, internal controls and SOPs to mitigate risk.</li></ul> Process, Team &amp; Stakeholder Management <ul><li>Coordinate with accounting, payroll and legal for information and cohesive execution.</li><li>Communicate tax positions and risks to finance controller and tax head</li></ul> Requirements: <ul><li>Chartered Accountant (CA) with 8–10 years progressive experience in India taxation covering direct tax, GST, international tax and transfer pricing.</li><li>Proven experience in a corporate tax function, Big Four or reputable tax advisory firm.</li><li>Experience handling tax audits, assessments, litigation support and interactions with tax authorities.</li><li>Experience with tax provisions under Ind AS/IFRS preferred.</li><li>Having certifications related to taxation is a plus</li><li>Excellent communication skills (written and verbal); fluent in English</li><li>Detail-oriented with a high sense of urgency and exceptional organizational skills</li><li>Excellent interpersonal and conflict management skills with the ability to operate with a team, customer service, and leadership mentality</li><li>Ability to effectively lead, manage, and prioritize multiple projects, while operating in a fast-paced, complex global organization with shifting schedules and priorities</li><li>Solid working experience and knowledge of SAP, BI tools and office software (Excel).</li></ul>

Responsibilities: Direct &amp; Indirect Tax Compliance: <ul><li>Lead monthly, quarterly and annual compliance for corporate income tax, TDS/TCS, GST and other indirect taxes.</li><li>Oversee preparation and filing of income tax returns, GST returns and related statutory filings within timelines.</li><li>Ensure accuracy of tax provisioning, reconciliations and workpapers for statutory and internal reporting.</li><li>International Taxation</li></ul> Transfer Pricing: <ul><li>Own transfer pricing policy and documentation (Master File, Local File), benchmarking studies and intercompany pricing reviews.</li><li>Manage TP audits, coordinate APAs/MAPs and defend positions before tax authorities.</li></ul> Audit, Assessments &amp; Dispute Management: <ul><li>Manage tax audits/assessments, prepare responses and coordinate with external counsel/advisors.</li><li>Track litigations, maintain position papers, risk assessments and provisions as required.</li></ul> Advisory &amp; Controls: <ul><li>Provide tax inputs for business initiatives, contracts, M&amp;A, restructurings and product pricing.</li><li>Implement and maintain tax policies, internal controls and SOPs to mitigate risk.</li></ul> Process, Team &amp; Stakeholder Management: <ul><li>Coordinate with accounting, payroll and legal for information and cohesive execution.</li><li>Communicate tax positions and risks to finance controller and tax head</li></ul> Requirements: <ul><li>Chartered Accountant (CA) with 8–10 years progressive experience in India taxation covering direct tax, GST, international tax and transfer pricing.</li><li>Proven experience in a corporate tax function, Big Four or reputable tax advisory firm.</li><li>Experience handling tax audits, assessments, litigation support and interactions with tax authorities.</li><li>Experience with tax provisions under Ind AS/IFRS preferred.</li><li>Having certifications related to taxation is a plus</li><li>Excellent communication skills (written and verbal); fluent in English</li><li>Detail-oriented with a high sense of urgency and exceptional organizational skills</li><li>Excellent interpersonal and conflict management skills with the ability to operate with a team, customer service, and leadership mentality</li><li>Ability to effectively lead, manage, and prioritize multiple projects, while operating in a fast-paced, complex global organization with shifting schedules and priorities</li><li>Solid working experience and knowledge of SAP, BI tools and office software (Excel).</li></ul>

Responsibilities: <ul><li>Support bulk cable team by tracking quality, compiling reports, assist with DOEs and product qualification</li><li>Organize and facilitate Design Review (DR) and Design Failure Modes &amp; Effects Analysis (DFMEA) reviews.</li><li>Implement quality planning and controls for prototype and/or sample builds.</li><li>Complete measurement system analysis for inspection systems and gages to be utilized for the project.</li><li>Review and analyze samples, quality issues and improvement actions during prototype making and CTAR/Qualification.</li><li>Coordinate sample preparation and certification for product verification and qualification testing.</li><li>Conduct and analyze process capability studies in support of Final Tool Approval (FTAR) for all tools and production lines associated with the project using the Comprehensive Tool Approval Report (CTAR).</li><li>Collaborate with MPDE, monitor process capability/data and oversee ongoing corrective actions as required.</li><li>Collaborate with corporate UL team / UL engineer/PJE/PQE for new certification. -Collaborate with PDE, analyze physical/SI data and make qualification report.</li><li>Collaborate with PDE, CA PDE/SI/MPDE, support SQE on outsourced cable quality control and improvement from bulk cable engineering side.</li><li>Preparation for prototype/sample making: -Organize and facilitate Design Review (DR) and Design Failure Modes &amp; Effects Analysis (DFMEA) reviews.</li><li>Complete measurement system analysis for inspection systems and gages to be utilized for the project.</li><li>Data Analysis:Monitor process physical/SI data.</li><li>Review and analyze samples, quality issues and improvement actions during prototype making and CTAR/Qualification.</li><li>Review 108 and finish 501 documents per customer requirement and industrial standards.</li><li>Coordinator during prototype/sample making: -Monitor process capability and oversee ongoing corrective actions as required.</li><li>Support MPDE on FACA.</li><li>Support PDE on design improvement.</li><li>Coordinator during outsourced cable qualification process:Review outsourced cable Physical data, SI data, Reliability data, stability data, give comments from bulk cable engineering side on supplier quality and product quality.</li></ul> Requirements:﻿ <ul><li>Bachelors or Masters Degree in science or technology.</li><li>10 years min. working experience in bulk cable design or manufacturing.</li><li>3 years team management experience.</li><li>Familiar with bulk cable knowledge, bulk cable manufacturing knowledge and machines knowledge.</li><li>Can work under the pressure.</li><li>Drive for results, good problem solving skills</li><li>Good communication skill, integrity, accountability and passion, Integrity, ccountability, team work</li><li>Good communication, interpersonal and management skills</li></ul>

Responsibilities: <ul><li>Perform preventive and corrective maintenance, troubleshooting, and repairs on facility infrastructure and critical utilities, including HVAC systems for cleanroom environment, compressed air and vacuum systems, clean utilities (WFI, purified water, clean steam), boilers, chillers, temperature control units, and effluent water treatment equipment.</li><li>Support equipment setup, calibration, qualification, and creation of maintenance plans of facility utilities and equipment.</li><li>Conduct round and inspection to monitor system performance and proactively address issues.</li><li>Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.</li><li>Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).</li><li>Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.</li><li>Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.</li><li>Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.</li><li>Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.</li><li>Provide technical support of production activities during absence of production support team members or when bandwidth is insufficient.</li></ul> Requirements:﻿ <ul><li>High school diploma or technical certificate required, Associate’s degree in a mechanical or technical field preferred.</li><li>3+ years of experience as a mechanic or technician maintaining utilities or facilities infrastructure in a pharmaceutical, biotech, or regulated manufacturing environment.</li><li>Experience with pharmaceutical manufacturing equipment and cleanroom protocols is highly desirable.</li><li>Strong troubleshooting skills for mechanical, electrical, and control system issues.</li><li>Familiarity with building management systems (BMS) and alarm monitoring systems.</li><li>Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.</li><li>Understanding of cGMP, contamination control, and safety regulations (OSHA, FDA, EU Annex 1).</li><li>Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.</li><li>Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).</li><li>Self-motivated with strong attention to detail, problem-solving skills, and the ability to work independently or in a team.</li><li>Willingness to work flexible hours, including weekends or off-shifts during production or commissioning activities.</li></ul> Work Environment: <ul><li>Hands-on role in a regulated, sterile pharmaceutical manufacturing facility with strict safety and aseptic requirements.</li><li>Requires frequent gowning, standing, and work in confined or classified areas.</li><li>Fast-paced startup environment, requiring adaptability, initiative, and a collaborative mindset.</li><li>Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.</li><li>Physical requirements include lifting climbing ladders, electrical troubleshooting, and working with hand and power tools</li></ul>

Responsibilities:﻿ <ul><li>Support in all production equipment maintenance in his area of responsibility.</li><li>Work on assignments that are less complex.</li><li>Assist engineers and senior technicians undertake more complex tasks.</li><li>Resolve simple problems with minimum guidance.</li><li>Undertake medium complex PM tasks with some guidance.</li><li>Provide proper handover and shift pass down.</li><li>Perform PM and tool calibrations as per planned and properly updated (both document as well as PM/Calibration stickers).</li><li>Perform type conversion including equipment fine-tuning and buy-off before releasing it to production.</li><li>Perform equipment repair and troubleshooting, maintaining it at minimum downtime.</li><li>Assist in maintaining inventory of spare parts.</li><li>Collaborate with senior technicians on equipment upgrades.</li><li>Compliance with CSR, EHS, QM, ESD, 5S standard and cleanroom protocol.</li></ul> Requirements: <ul><li>Diploma in Engineering or equivalent Technical Certificate.</li><li>Fresh graduates and above.</li><li>Knowledge of software applications such as MS Power Point, Excel, and Word.</li><li>Level 1 equipment troubleshooting skills on at least 1 main equipment type.</li><li>Basic mechanical and electrical skills.</li></ul>

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7 ca certificate Jobs found

Executive Assistant and Administrative Lead

Associate Director RA & QA

Tax Lead

Tax Lead

Staff Quality & Reliability Engineer

Facility Mechanic

Machine Maintenance Technician

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7 ca certificate Jobs found

Executive Assistant and Administrative Lead

Associate Director RA & QA

Tax Lead

Tax Lead

Staff Quality & Reliability Engineer

Facility Mechanic

Machine Maintenance Technician

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

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