Senior Analyst – Regulatory Labeling
Location: Mumbai, Maharashtra, India
Employment Type: Full-Time
Industry: Pharmaceuticals | Regulatory Affairs | Labeling & Artwork
Experience Required: 3–5 years
Date Posted: 11 December 2025
Company: Apotex Inc.
Role Overview
Apotex Inc. is seeking an experienced Senior Analyst – Regulatory Labeling to support regulatory labeling activities for new product development and lifecycle management, primarily for the Canada and US markets. This role is critical in ensuring timely, accurate, and compliant labeling submissions aligned with global regulatory requirements and Health Authority expectations.
The position involves close collaboration with internal regulatory teams, vendors, and affiliates, with responsibility for label creation, updates, artwork coordination, and submission tracking throughout the product lifecycle.
Key Responsibilities
Perform labeling creation, updates, and maintenance for New Product Development (NPD) and Product Lifecycle Management (PLM) activities.
Prepare, review, and submit regulatory labeling documents for Canada and US markets in accordance with submission type and regulatory guidelines.
Coordinate with internal compilers, vendors, and affiliates to ensure timely creation and update of labeling artwork.
Act as a peer-level interface with Canada affiliates and internal ARPL teams to address Health Authority queries and requirements.
Maintain and update labeling trackers and systems including RIMS, CCRs, and internal tracking tools to ensure submission timelines are met.
Author and review product labels and monographs, including decision-making on change applicability and regulatory impact.
Manage final product labeling submissions and communicate effectively with regional teams and regulatory authorities to support approvals.
Support eCTD-based labeling submissions, including ESG submissions where applicable.
Ensure completion and quality review of PM checklists and form documentation for both compiler and reviewer activities.
Prioritize labeling requirements and plan submissions based on regulatory and business priorities.
Maintain working knowledge of labeling systems and software such as LAMS.
Train new team members on labeling tools, systems, and processes.
Stay current with evolving global and regional labeling regulations and international regulatory guidelines.
Ensure full compliance with Apotex quality systems, safety standards, and global ethics and compliance programs.
Required Qualifications
Education:
Master’s degree in Pharmacy (2 years) with specialization in Pharmacology
OR
Bachelor’s degree in Pharmacy (4 years)
Experience Requirements
Minimum 3 years of hands-on experience in regulatory labeling within the pharmaceutical industry.
Prior experience in Global Regulatory Affairs (GRA) Labeling is strongly preferred.
Experience supporting Canada and/or US regulatory submissions.
Exposure to labeling lifecycle activities, artwork coordination, and Health Authority interactions.
Technical Skills & Competencies
Strong knowledge of eCTD dossier compilation and regulatory submissions.
Working understanding of labeling development, monographs, and artwork management.
Proficiency in MS Excel, PowerPoint, and MS Office tools.
Familiarity with regulatory systems such as RIMS and LAMS.
Strong organizational, documentation, and tracking skills.
Excellent written and verbal communication skills with the ability to collaborate across global teams.
Ability to prioritize multiple projects and meet regulatory timelines in a fast-paced environment.
Why Join Apotex
Apotex is a global pharmaceutical leader committed to improving access to affordable, high-quality medicines worldwide. Joining Apotex means working in a collaborative, values-driven environment that emphasizes compliance, innovation, and professional growth while contributing to meaningful global healthcare outcomes.
Diversity, Equity & Inclusion
Apotex is committed to providing a respectful, inclusive, and accessible workplace. Reasonable accommodations are available throughout the recruitment process for applicants with disabilities, in accordance with applicable regulations.
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