Senior Analyst – Regulatory Labeling
Company: Apotex Inc.
Location: Mumbai, Maharashtra, India (400079)
Posting Date: February 7, 2026
Employment Type: Full-Time
About Apotex Inc.
Apotex Inc. is a Canadian-based global pharmaceutical organization dedicated to improving access to affordable, high-quality medicines and health products worldwide. With a strong portfolio spanning generic, biosimilar, innovative branded pharmaceuticals, and consumer health products, Apotex operates across more than 75 countries. Headquartered in Toronto, the company maintains a significant global footprint across North America, Latin America, and India.
Position Overview
The Senior Analyst – Regulatory Labeling is responsible for end-to-end regulatory labeling activities supporting New Product Development (NPD) and Product Life Cycle Management (PLCM) for products in the Canadian market. This role involves close collaboration with internal regulatory teams, vendors, and affiliates to ensure accurate, compliant, and timely labeling submissions to Health Authorities.
Key Responsibilities
Regulatory Labeling and Submissions
Coordinate and prepare regulatory labeling submissions for Canada in accordance with Health Canada requirements
Develop, update, and maintain product labels and product monographs for new product development and lifecycle management activities across the US and Canadian markets
Prepare and submit supporting documentation for labeling updates based on submission type
Author regulatory responses and assess applicability of labeling changes in alignment with regulatory guidance
Cross-Functional and Vendor Coordination
Liaise with internal compilers, regional regulatory teams, and Canadian affiliates to address data availability issues and regulatory queries
Coordinate with external vendors and artwork partners to ensure timely creation, review, and approval of labeling artwork
Communicate effectively with Health Authorities and internal stakeholders to facilitate timely approvals
Tracking, Systems, and Quality
Maintain labeling trackers and regulatory systems, including RIMS, CCRs, and internal tracking tools, to ensure submission timelines are met
Ensure completion of project management and quality checklists by compilers and reviewers to maintain submission quality
Prioritize labeling activities and plan submissions based on regulatory and business timelines
Maintain working knowledge of labeling software and electronic submission tools, including eCTD workflows
Compliance, Training, and Continuous Improvement
Ensure all activities comply with established regulatory, quality, and safety standards
Stay current with Canadian labeling regulations, international guidelines, and evolving regulatory expectations
Train and mentor new team members on labeling systems, including LAMS software and associated processes
Support internal compliance programs, quality systems, and organizational values
Required Experience and Qualifications
Education:
Master’s degree in Pharmacy (M.Pharm) with specialization in Pharmacology, or
Bachelor’s degree in Pharmacy (B.Pharm)
Experience:
Minimum 3 to 4 years of experience in Regulatory Affairs with a strong focus on Regulatory Labeling
Prior experience supporting Canada market labeling activities is required
Experience in pharmaceutical industry environments, CROs, or global regulatory operations is preferred
Key Skills and Knowledge:
Hands-on experience with eCTD dossier compilation and regulatory submissions
Strong understanding of Canadian regulatory labeling requirements and product monograph standards
Proficiency in regulatory tracking systems and labeling software
Strong communication, stakeholder management, and documentation skills
Proficient in MS Excel, PowerPoint, and other Microsoft Office applications
Why Join Apotex
Apotex offers a collaborative and inclusive work environment where regulatory professionals contribute directly to global patient access and regulatory excellence. The organization supports professional development through exposure to global regulatory frameworks and complex product portfolios.
Equal Opportunity and Accessibility
Apotex Inc. is committed to providing an inclusive, accessible, and equitable workplace. Reasonable accommodations are available throughout the recruitment process for candidates with disabilities. All accommodation-related information is handled confidentially to support an accessible candidate experience.
Gujarat :
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Hajipur | Patna |Kerala :
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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Frank Scottile Blvd |Missouri :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
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Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Renfrew | Mississauga | Uxbridge | Australia | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
Tel Aviv | Be'Er Sheva | Yavne | Kfar Saba | Netanya |Remote :
Regulatory Labeling Manager (NA and LATAM Only) | Texas | McFarland | Hammond | Bishop | Castlebar | Switzerland | Manipal | Tulsa | Belgium | Lousiana | Remote, USA | Leinster | Thailand | Zaragoza | Bountiful | Medan | Remote - Africa | Blue Bell | Hungary | Ireland | Remote - Middle East | Xzagreb | Riga | Melbourne | Springville | Remote | Lenexa | Green Way | Minnesota | Nairobi | Slovakia | Victoria | Remote - Europe | Faridabad | French | Remote - South America (Latin Americal) |Republic of Colombia :
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Ciudad de México | New Mexico |Dubai :
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Riyadh | Rabigh | King Abdullah Economic City | Najran | Jeddah | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
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