Lead Executive – Global Regulatory Affairs
Company: Apotex Inc.
Location: Mumbai, Maharashtra, India (400079)
Posting Date: January 30, 2026
Employment Type: Full-Time
About Apotex Inc.
Apotex Inc. is a Canadian-based global pharmaceutical organization dedicated to delivering high-quality, affordable medicines worldwide. With operations spanning manufacturing, research and development, and commercial activities, Apotex serves patients across more than 75 countries. The company’s vertically integrated model supports a strong portfolio of generic, biosimilar, and specialty products, reinforcing its commitment to global healthcare access.
Position Overview
The Lead Executive – Global Regulatory Affairs will play a critical role in managing product lifecycle activities for Apotex products across multiple international markets. This position is responsible for regulatory compliance, post-approval change management, and coordination of regulatory submissions while supporting regulatory strategy execution and team operations. The role requires strong expertise across regulated and semi-regulated markets, including the US, Canada, Europe, Australia–New Zealand, and ROW regions.
Key Responsibilities
Regulatory Lifecycle Management and Submissions
Manage regulatory product lifecycle activities, including post-approval changes, variations, and supplements across global markets
Prepare, review, and coordinate quality regulatory submissions to ensure timely approvals
Assess, compile, and submit deficiency responses in alignment with regulatory timelines
Prepare submission and approval notifications for applications filed with health authorities
Regulatory Compliance and Documentation
Maintain accurate regulatory documentation and databases in compliance with internal systems, SOPs, and regulatory requirements
Review change control documentation and provide regulatory impact assessments
Ensure adherence to regulatory policies, quality standards, and compliance programs
Draft or support development of regulatory SOPs and guidelines as required
Cross-Functional Collaboration and Stakeholder Management
Coordinate with internal teams including Quality, Manufacturing, Supply Chain, and R&D to support regulatory submissions
Liaise with third-party manufacturers, agents, and suppliers to obtain documentation required for regulatory filings
Communicate effectively with external partners and internal stakeholders to resolve complex regulatory issues
Leadership and Team Support
Provide regulatory guidance and operational support to team members on assigned projects
Act as a backup for team members and support overall team deliverables as needed
Support the Reporting Manager in submission planning, regulatory strategy development, and knowledge-building initiatives
Assist in onboarding and training of new regulatory team members
Required Experience and Qualifications
Education:
Graduate or Postgraduate degree in Pharmacy, Chemistry, or Life Sciences
Experience:
Minimum 7 years of hands-on Regulatory Affairs experience in global markets
Proven experience in post-approval change management and lifecycle submissions
Exposure to US, Canada, EU, Australia–New Zealand, and ROW markets
Key Skills and Knowledge:
Strong understanding of regulatory requirements for variations and supplements
Experience with regulatory databases, trackers, and submission documentation
Ability to interpret global regulatory guidelines and execute regulatory strategies
Excellent coordination, communication, and problem-solving skills
Ability to manage multiple priorities in a deadline-driven, global environment
Why Join Apotex
Apotex offers a collaborative and inclusive work environment where regulatory professionals can grow their technical expertise while contributing to global patient access to medicines. Employees benefit from exposure to diverse regulatory markets, cross-functional collaboration, and a culture built on integrity, quality, and continuous improvement.
Equal Opportunity and Accessibility
Apotex Inc. is committed to fostering an inclusive and accessible workplace. Reasonable accommodations are available throughout the recruitment process for applicants with disabilities, ensuring a fair and supportive candidate experience.
Gujarat :
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