Senior Analyst – Regulatory Labeling
Location: Mumbai, Maharashtra, India
Job Type: Full-Time
Work Model: Flexible / Onsite
Company: Apotex Inc.
Date Posted: Jan 9, 2026
About Apotex
Apotex Inc. is a Canadian-based global pharmaceutical leader, committed to improving patient access to affordable, innovative medicines. With a diverse portfolio spanning generic, biosimilar, branded pharmaceuticals, and consumer health products, Apotex operates in more than 75 countries, including India, the US, and Mexico. Headquartered in Toronto, Apotex is the largest Canadian pharmaceutical company with a strong focus on regulatory excellence and product lifecycle management.
For more details, visit: www.apotex.com
Role Overview
We are seeking a Senior Analyst – Regulatory Labeling to join our Global Regulatory Affairs (GRA) Labelling Team. This role is responsible for label creation, lifecycle maintenance, and regulatory submission activities for products in the Canada market and other assigned territories. The ideal candidate will ensure compliance with health authority regulations, coordinate with internal and external stakeholders, and maintain timely and accurate labeling deliverables.
Key Responsibilities
Coordinate and prepare regulatory submissions related to product labeling for new product development and lifecycle maintenance.
Collaborate with internal compilers, vendors, and affiliates to address data queries and artwork updates.
Maintain and update all tracking tools and trackers (e.g., RIMS, tracking sheets, CCR) to ensure timely submissions to health authorities.
Author, review, and approve label content and monographs based on regulatory requirements.
Assess and implement labeling changes following international guidelines and local regulations (Canada and US).
Prepare and manage ESG submissions and regulatory correspondence with authorities.
Review, validate, and ensure quality of submission dossiers (eCTD format), checklists, and forms.
Mentor and train new team members on LAMS software and labeling processes.
Stay updated on changes in labeling regulations and best practices to support compliance.
Collaborate with cross-functional teams to ensure alignment between Regulatory, R&D, Quality, and Clinical teams.
Required Knowledge & Skills
Strong understanding of labeling software (LAMS) and dossier compilation.
Knowledge of regulatory labeling requirements for Canada and US markets.
Proficiency in MS Office applications (Excel, PowerPoint, Word) and internet-based research.
Excellent communication, presentation, and organizational skills.
Strong attention to detail, ability to prioritize tasks, and meet regulatory timelines.
Ability to mentor junior colleagues and provide regulatory guidance.
Education & Experience
Master’s in Pharmacy (2 years) with specialization in Pharmacology OR Bachelor’s in Pharmacy (4 years).
Minimum 3–5 years of experience in regulatory labeling, preferably within the pharmaceutical industry.
Hands-on experience in label creation, product lifecycle maintenance, regulatory submissions, and dossier management.
Familiarity with molecular biology or laboratory techniques is an advantage.
Preferred Experience:
Experience working with Apotex or global pharmaceutical companies.
Exposure to GRA labeling team activities and health authority submissions.
Why Join Apotex
Contribute to a global pharmaceutical leader improving patient access to healthcare.
Collaborate with cross-functional teams and international regulatory stakeholders.
Opportunities for career growth in regulatory affairs and labeling management.
Work in a diverse, inclusive, and supportive environment that values continuous learning and development.
Apply today on thepharmadaily.com to join as a Senior Analyst – Regulatory Labeling and advance your career in global regulatory affairs.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Siliguri |Illinois :
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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 :
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Frank Scottile Blvd |Missouri :
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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 :
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Wavre |Tipperary :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
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Wuhan |Capital of Netherland :
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Haarlem |South Holland :
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 :
Mississauga | Richmond Hill | Uxbridge | Renfrew | Australia | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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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 :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Be'Er Sheva | Tel Aviv | Netanya | Yavne | Kfar Saba |Remote :
Victoria | Manipal | Minnesota | Melbourne | Remote - Europe | Xzagreb | Switzerland | French | Green Way | Ireland | Remote, USA | Tulsa | Lenexa | Remote | Remote - Middle East | Zaragoza | Regulatory Labeling Manager (NA and LATAM Only) | Riga | Nairobi | Texas | Belgium | Castlebar | Hammond | Lousiana | McFarland | Slovakia | Remote - Africa | Hungary | Leinster | Bountiful | Bishop | Blue Bell | Thailand | Springville | Medan | Remote - South America (Latin Americal) | Faridabad |Republic of Colombia :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
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Ciudad de México | New Mexico |Dubai :
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Khulais | Najran | Jeddah | Rabigh | King Abdullah Economic City | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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