Lead Executive – Global Regulatory Affairs
Company: Apotex Inc.
Job Location: Mumbai, Maharashtra, India – 400079
Employment Type: Full-Time
Function: Global Regulatory Affairs
Date Posted: January 1, 2026
About Apotex Inc.
Apotex Inc. is a Canadian-based global pharmaceutical company dedicated to delivering high-quality, affordable medicines to patients worldwide. With operations spanning manufacturing, R&D, and commercial functions, Apotex serves patients in over 75 countries. The company’s vertically integrated model supports the development and commercialization of generic, biosimilar, and specialty pharmaceutical products.
Position Overview
Apotex is seeking a Lead Executive – Global Regulatory Affairs to manage and support global product lifecycle management (PLCM) activities across multiple regulatory markets. This role is responsible for regulatory submissions, post-approval change management, regulatory database maintenance, and cross-functional coordination to ensure compliance and timely approvals.
The position requires strong expertise in global regulatory frameworks, hands-on experience with post-approval variations, and the ability to independently manage complex regulatory projects across US, Canada, EU, Australia–New Zealand, and ROW markets.
Key Responsibilities
Regulatory Lifecycle Management & Submissions
Manage product lifecycle management (PLCM) activities for assigned products across global markets.
Prepare, review, and submit high-quality post-approval regulatory submissions and variation packages to health authorities.
Ensure timely preparation and communication of submission and approval notifications.
Regulatory Compliance & Documentation
Maintain accurate regulatory documentation and databases in line with established systems, SOPs, and regulatory procedures.
Review and assess change control documentation to determine appropriate regulatory filing strategies.
Ensure regulatory submissions meet quality, compliance, and timeline expectations.
Deficiency Management & Health Authority Interactions
Coordinate and compile responses to health authority deficiency letters within defined timelines.
Interpret regulatory guidelines and policies to resolve complex submission-related issues.
Communicate with external agents, suppliers, and third-party manufacturers to obtain data required for submissions.
Cross-Functional & Stakeholder Collaboration
Collaborate with internal departments including Quality, R&D, Manufacturing, Supply Chain, and Regulatory Operations to support submissions.
Provide regulatory guidance to internal teams to ensure consistency and compliance across markets.
Act as a regulatory liaison to resolve issues impacting submission quality or timelines.
Team Support & Leadership
Support the Reporting Manager in regulatory strategy development and execution.
Assist in onboarding and training of new team members, as required.
Act as a backup for team members and contribute to the overall efficiency and functioning of the regulatory team.
Promote a collaborative, accountable, and quality-driven work culture aligned with organizational values.
Governance, SOPs & Continuous Improvement
Ensure adherence to regulatory SOPs, RA policies, and global compliance programs.
Draft or support the development of regulatory SOPs and guidelines where applicable.
Contribute to continuous improvement initiatives within Global Regulatory Affairs.
Educational Qualifications
Graduate or Postgraduate degree in Pharmacy, Chemistry, or Life Sciences from a recognized institution.
Experience Requirements
Minimum 7+ years of relevant experience in Global Regulatory Affairs, with hands-on exposure to:
US, Canada, EU, Australia–New Zealand, and ROW markets
Post-approval change submissions and variation package compilation
Demonstrated experience managing PLCM activities and regulatory submissions in a regulated pharmaceutical environment.
Key Skills & Competencies
Strong knowledge of global post-approval change requirements and regulatory submission processes.
Expertise in regulatory documentation, variation management, and lifecycle maintenance.
Ability to interpret and apply global regulatory guidelines and policies.
Excellent organizational, analytical, and problem-solving skills.
Strong written and verbal communication skills with the ability to work across global teams.
High attention to detail and ability to manage multiple regulatory projects simultaneously.
Proficiency in regulatory databases, trackers, and documentation systems.
Work Environment & Values
Apotex promotes a culture of collaboration, integrity, accountability, and continuous learning. Employees are expected to operate in full compliance with global ethics, quality, safety, and HR policies while contributing to a respectful and inclusive workplace.
Diversity, Inclusion & Accessibility
Apotex is an equal opportunity employer committed to creating an inclusive and accessible work environment. Reasonable accommodations are available throughout the recruitment process for applicants with disabilities.
Disclaimer
This job description outlines the general nature and scope of the position and is not intended to be an exhaustive list of responsibilities or qualifications. Apotex Inc. reserves the right to amend duties based on business requirements.
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Niš |Bohemia :
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