{"id":2982594,"url":"https://alion.io/job/apotex-executive-api-technical","title":"Executive - API Technical","company":{"id":1790883,"name":"Apotex","domain":"apotex.com","url":"https://alion.io/company/apotex-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Sales","role_family":"Sales","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Mumbai, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":9500,"max_usd":28000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":44},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Microsoft Excel","optional":false},{"name":"Outlook","optional":false},{"name":"SharePoint","optional":false}],"status":"live","first_seen_at":"2026-10-03T02:00:00Z","employer_posted_date":"2026-10-03","last_verified_at":"2026-10-22T08:41:44Z","board_verified":true,"closed_at":null,"days_open":19,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":19},"description":"About Apotex Inc.\nApotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.\nFor more information visit: www.apotex.com.\nJob Summary\nIn this role, the incumbent will liaise and work directly with the appropriate functional groups within the Apotex group of companies and external raw material manufacturers on technical, quality, and regulatory matters for New Product Development (NPD), Product Life-Cycle Management (PLCM), and Commercial Projects related to active pharmaceutical ingredients (APIs) and excipients. Responsible to provide a high level of expertise with regards to drug master file (DMF) review, DMF deficiencies, DMF changes, also known as supplier driven changes, raw material out-of-specification (OOS)/out-of-trend (OOT) events resolution between Apotex and its suppliers.\nThis involves:\nDriving the technical aspects of raw material sourcing projects in the region or problem-event resolution by defining, planning, monitoring and reporting project progress/performance against timelines and deliverables.\nUpdating the Sourcing Hub Leader, Global API Technical Managers and other stakeholders on project progress.\nFocusing on the end goals of delivering API technical assessments and problem resolutions with suppliers in the sourcing region.\nJob Responsibilities\nEnsure that Apotex achieves the most rapid approval on drug product submission dossiers, the incumbent with be the lead reviewer for sourcing region originated DMFs (open-part and closed-part, when available)\nEnsure that the supplier DMFs conform to the most current requirements of the filing jurisdiction, for example, ICH guidelines (Q3, Q11, M7 etc.), with special attention to the most recent regulator mandated filing requirements\nDMF review must extract and disseminate relevant information needed to assist formulation development, setting of appropriate drug substance specification, and shipping and storage of materials\nContribute to and manage response plans with manufacturers and Apotex internal groups for DMF deficiency responses, so as to not disrupt application approval timelines or the material supply chain.\nManage the coordination of NPD and PLCM projects and process/manufacturing site changes between the sourcing region suppliers and GAPI Site Technical teams (and when required, directly with Apotex Analytical Development, Regulatory Affairs, and Formulation Development) to ensure a seamless submission process\nCoordinate the data (OOS investigation, rejection, OOT investigation, CAPA, etc) and information flow between suppliers and GAPI Site Technical teams and/or quality assurance teams for all quality and technical initiatives (Nitrosamine, Allergen, Forced degradation, Stability data, etc) quality related investigations surrounding active ingredients and excipients from the regional hub’s portfolio.\nWorking with suppliers, investigate and resolve technical, quality, and regulatory issues related to active ingredients and excipients for NPD, PLCM and Commercial drug products with regard to OOS events, Certificate of Analysis (CofA) discrepancies, documentation for impurities and active standards, manufacturing process changes or site relocations, DMF deficiencies, DMF changes, and specification changes, method alignment\nCoordinate specifications revisions (monograph updates or new project status), as well as industry initiatives, between Apotex and raw material suppliers\nAssist the Global API manufacturer selection process for NPD and PLCM projects through cross-functional communication with the technical teams at the GAPI regional hubs and GAPI site teams\nContribute information content to GAPI supply databases as required. Maintain the Apotex SharePoint database for DMF and DMF annual updates for the regional hub portfolio\nPerform all other tasks and duties as may, from time to time, be assigned (for example, Confidentiality Disclosure Agreements with suppliers)\nAll other duties as assigned.\nJob Requirements\n Education:Graduate/ Post Graduate in Science/ Commerce, Economist (Business Administration) or Scientist (Chemistry, Chemical engineering, Pharmacology etc.)\n\nKnowledge, Skills and AbilitiesMust possess knowledge of the technical, quality compliance, and regulatory requirements related to the sourcing of APIs.\nMust possess the ability to provide solutions to a variety of problems of moderate scope and complexity.\nAbility to read and interpret complex technical documents. Ability to write detailed business correspondence.\nAbility to work with managers or directors and communicate ambiguous concepts.\nExcellent communication and interpersonal skills.\nStrong organizational skills; ability to work independently and manage priorities.\nDemonstrated knowledge of the generic API new product development process\nAbility to travel to supplier sites or industry trade conventions when required.\nKnowledge of and experience with the MS-Office suite of products; with particular emphasis on MS-Word, MS Outlook and MS-Excel. Willingness to learn and become proficient with new business software applications as they are introduced to the organization.\n\nExperience:8 - 10 years of experience in the pharmaceutical industry.\n\nAt Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed.\nWe offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.","description_format":"text","description_chars":6025,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Generic Drugs"],"lifecycle":[{"event":"open","at":"2026-10-21T07:45:49Z"}],"visa":[],"liveness":{"score":41,"band":"fade","label":"Fading","p_open":1,"p_active":0.747,"p_room":0.55,"age_days":19,"expected_fill_days":19,"reasons":["conf:1","win:tail"],"computed_at":"2026-10-22T06:10:10Z"},"pay":null,"html_url":"https://alion.io/job/apotex-executive-api-technical","json_url":"https://alion.io/job/apotex-executive-api-technical.json","meta":{"generated_at":"2026-10-23T00:06:00Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":166,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-24T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1790883},"rest":"https://alion.io/mcp/rest/get_company?id=1790883"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fapotex-executive-api-technical"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fapotex-executive-api-technical"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fapotex-executive-api-technical"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/apotex-executive-api-technical\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fapotex-executive-api-technical"}]}