Job Title: Lead Executive – Global Regulatory Affairs (PLCM & Post-Approval Submissions)
Location: Mumbai, Maharashtra, India (400079)
Company: Apotex Inc.
Employment Type: Full-Time
Date Posted: January 30, 2026
Industry: Regulatory Affairs | Global Pharma | Generics | Biosimilars | Life Cycle Management
Apotex Inc., a global pharmaceutical leader in generic, biosimilar, and specialty medicines, is hiring a Lead Executive – Global Regulatory Affairs in Mumbai, India. This role is designed for experienced regulatory professionals with strong expertise in post-approval change submissions, product life cycle management (PLCM), global variation filings, and multi-market regulatory strategy execution.
This opportunity is ideal for candidates with extensive experience handling submissions across US, Canada, EU, Australia-New Zealand (AUS-NZ), and Rest of World (ROW) markets.
Apotex is a Canadian-based global health company employing over 7,000 professionals across manufacturing, R&D, and commercial operations. With a presence in more than 75 countries, Apotex focuses on delivering affordable, high-quality medicines through vertical integration and innovation in generics and biosimilars.
The Lead Executive – Global Regulatory Affairs is responsible for managing the product life cycle of approved products across multiple global markets. The role includes preparation, review, coordination, and submission of regulatory documentation for post-approval variations, deficiency responses, and compliance maintenance.
The position supports regulatory strategy execution, ensures alignment with global guidelines, and collaborates with cross-functional teams to achieve timely regulatory approvals.
Manage post-approval regulatory submissions across US, CAN, EU, AUS-NZ, and ROW markets.
Prepare and review variation packages and post-approval supplements.
Evaluate and assess change control documentation.
Ensure accurate compilation and submission of regulatory deficiency responses.
Maintain regulatory compliance throughout the product life cycle.
Prepare, review, and submit high-quality regulatory documentation in line with global guidelines.
Interpret regulatory requirements and implement appropriate submission strategies.
Resolve complex regulatory issues related to global submissions.
Coordinate with third-party manufacturers for documentation requirements.
Maintain regulatory databases, trackers, and submission logs with high accuracy.
Ensure adherence to SOPs, regulatory policies, and global compliance standards.
Draft or update SOPs and regulatory guidelines when required.
Maintain review checklists, deficiency trackers, and submission spreadsheets.
Work closely with Quality, Manufacturing, R&D, and Supply Chain teams to gather submission data.
Communicate with regulatory agents, suppliers, and external partners.
Provide regulatory guidance to internal teams for successful submission outcomes.
Support Reporting Manager in developing submission strategies and enhancing technical capability within the team.
Act as a back-up for team members when required.
Support onboarding and training of new team members.
Contribute to team efficiency, knowledge-sharing, and process improvements.
Promote collaboration, compliance, and quality standards across the department.
Minimum 7 years of experience in Global Regulatory Affairs.
Proven experience handling post-approval change submissions and PLCM activities.
Hands-on experience in regulatory submissions for:
United States (US FDA)
Canada (Health Canada)
European Union (EMA & National Agencies)
Australia-New Zealand (TGA/Medsafe)
Rest of World (ROW) markets
Experience compiling and reviewing variation packages and deficiency responses.
Strong knowledge of global regulatory frameworks and submission requirements.
Graduate or Post-Graduate Degree in:
Pharmacy
Chemistry
Life Sciences
Advanced regulatory certifications are considered an advantage.
Strong expertise in post-approval regulatory strategy and variation submissions.
In-depth understanding of global regulatory guidelines and policies.
Excellent documentation review and quality control capabilities.
Strong analytical and problem-solving skills.
Ability to manage multiple complex submissions under strict timelines.
Effective stakeholder communication and cross-functional collaboration.
Proficiency in regulatory databases and tracking systems.
High level of compliance awareness and ethical standards.
Office-based role in Mumbai, India.
Exposure to global regulatory submissions across multiple jurisdictions.
Opportunity to work in a vertically integrated global pharmaceutical organization.
Collaborative and compliance-driven regulatory environment.
This role offers progression into:
Senior Regulatory Affairs Manager
Global Regulatory Strategy Lead
Regulatory Compliance Manager
Associate Director – Global Regulatory Affairs
Professionals in this position gain extensive experience in multi-market submissions, regulatory intelligence, and life cycle management strategy execution.
Global exposure across 75+ markets.
Strong focus on generics, biosimilars, and specialty pharmaceuticals.
Culture built on collaboration, perseverance, courage, and passion.
Commitment to ethics, quality, safety, and regulatory excellence.
Apotex fosters an inclusive and accessible work environment and provides accommodations for applicants with disabilities throughout the recruitment process.
If you have 7+ years of global regulatory affairs experience with strong expertise in post-approval change management across US, EU, Canada, AUS-NZ, and ROW markets, this Mumbai-based opportunity offers strategic exposure in global product life cycle management.
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