About Apotex Inc.
Apotex Inc. is a leading Canadian-based global health company committed to providing high-quality, affordable medicines to patients worldwide. With nearly 7,200 employees globally, Apotex operates in manufacturing, R&D, and commercial sectors. Apotex medicines reach over 75 countries, focusing on developing and delivering generic, biosimilar, and specialty pharmaceutical products. For more information, visit www.apotex.com.
Job Title: Senior Analyst, GRA Labelling
Job Summary:
The Senior Analyst, GRA Labelling, oversees all labeling updates and maintenance for New Product Development (NPD) and Product Lifecycle (PLC) updates targeting the Canadian market. This role requires collaboration with compilers, vendors, and affiliates to ensure accurate label creation and timely artwork updates. The incumbent manages labeling trackers and ensures compliance with health authority requirements while maintaining high submission quality.
Key Responsibilities:
Label Development & Updates:
Prepare and update labels and monographs for NPD and PLC maintenance for Canada and U.S. markets.
Author responses to health authority queries and serve as a decision-maker for label changes.
Manage label submission priorities and plan timelines accordingly.
Coordination & Communication:
Interact with compilers and affiliates to address data-related queries and issues.
Coordinate with vendors/affiliates for artwork creation and updates.
Maintain effective communication with regulatory authorities and internal stakeholders for timely product approvals.
Regulatory Compliance & Tracking:
Prepare and submit supporting documents for labeling submissions in Canada.
Maintain trackers (RIMS, CCR, etc.) for efficient label update processes.
Conduct ESG submissions and maintain submission records.
Stay updated on labeling regulations and ensure adherence to regulatory and safety compliance standards.
Team Support & Training:
Train new team members on LAMS software and related processes.
Review assigned tasks and ensure submission quality using PM and form checklists.
General Responsibilities:
Demonstrate Apotex's core values of Collaboration, Courage, Perseverance, and Passion.
Adhere to Apotex’s Global Business Ethics and Compliance Program, safety, and HR policies.
Perform additional duties as assigned.
Job Requirements:
Education:
Master’s in Pharmacy (Pharmacology specialization) – 2 years
Bachelor’s in Pharmacy – 4 years
Knowledge, Skills, and Abilities:
Proficiency in dossier compilation via eCTD.
Knowledge of animal assay techniques, molecular biology techniques (gel electrophoresis, DNA extraction, PCR), and oral dosing methods.
Computer skills: Advanced knowledge of MS Excel, PowerPoint, and MS Office.
Effective communication and presentation skills.
Organizational and interpersonal skills.
Experience:
3 years 7 months at Apotex Research Private Limited, Global Business Services – Senior Analyst, GRA Labelling Team.
3 months at Saifee Hospital – Clinical Pharmacist.
Why Join Apotex?
Diverse Opportunities: Work on innovative pharmaceutical projects targeting global health needs.
Commitment to Inclusion: Apotex fosters a workplace where all employees feel valued and supported.
Supportive Environment: Accommodations are available for applicants with disabilities during the recruitment process.
Take the next step in your career and contribute to enhancing healthcare worldwide with Apotex. Apply now!
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Delhi | India | New Delhi | PAN-India |Assam :
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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
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Bloomington | West Lafayette |Florida :
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Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
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Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
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Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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China | Quarry Bay |Liaoning :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Italy |Lombardy :
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Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bucharest |Buenos Aires :
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New Mexico | Ciudad de México |Dubai :
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Kyiv |Lima Region :
Lima |France :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
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