Assistant Manager – Global Regulatory Affairs
Location: Mumbai, Maharashtra, India
Job Type: Full-Time
Company: Apotex Inc.
Date Posted: Jan 27, 2026
About Apotex
Apotex Inc. is a Canadian-based global pharmaceutical leader, dedicated to improving patient access to affordable and innovative medicines. With a diverse portfolio spanning generic, biosimilar, and branded pharmaceuticals, Apotex serves millions of patients worldwide. Headquartered in Toronto and operating across the US, Mexico, India, and other global markets, Apotex combines regulatory expertise, innovative R&D, and commercial excellence to maintain its position as a global health partner of choice.
Visit www.apotex.com for more information.
Role Overview
We are seeking an Assistant Manager – Global Regulatory Affairs to lead and manage our Regulatory Affairs team in Mumbai. This role focuses on post-launch variation submissions, regulatory compliance, and product lifecycle management (PLCM) across key markets including US, Canada, EU, Australia/New Zealand, and ROW.
The successful candidate will ensure timely, high-quality submissions, provide technical leadership, and support team development, while driving continuous improvement in regulatory processes.
Key Responsibilities
Team Leadership & Management:
Lead, mentor, and manage the Regulatory Affairs team, providing coaching, training, and performance development.
Schedule, prioritize, and assign PLCM submissions, deficiency responses, and change control assessments.
Conduct performance reviews, one-on-one meetings, and development plans for team members.
Regulatory Affairs & Compliance:
Review, compile, and submit post-launch variations and deficiency responses to regulatory agencies.
Assess Change Control Records (CCR), Supplier-Driven Changes (SDC), pre-CMC changes, and other regulatory projects.
Maintain product documentation, databases, and trackers (submission spreadsheets, deficiency trackers, review checklists).
Ensure high-quality submissions for first-cycle approval by regulatory authorities.
Support process improvements and implement new procedures for smoother team operations.
Stakeholder Engagement:
Coordinate with internal teams and affiliates to resolve regulatory issues and meet project timelines.
Liaise with cross-functional departments (R&D, QA, Clinical, Labeling) to address queries and ensure compliance.
Act as a designate to the Reporting Manager, representing the team in high-level discussions.
Process & Culture:
Foster a culture of teamwork, collaboration, trust, and empowerment.
Encourage open communication to enhance engagement and performance.
Ensure team adherence to company policies, global compliance programs, and regulatory guidelines.
Required Skills & Competencies
Strong knowledge of post-approval regulatory submissions and variation package compilation across US, CAN, EU, AUS-NZ, and ROW markets.
Expertise in CMC document writing and review.
Proven leadership and mentoring skills, with the ability to manage and develop a high-performing team.
Excellent communication, organizational, and problem-solving skills.
Ability to prioritize multiple projects, meet tight deadlines, and maintain high-quality deliverables.
Education & Experience
Graduate or Postgraduate degree in Chemistry, Pharmacy, Life Sciences, or related scientific/business discipline.
Minimum 11 years of regulatory affairs experience across global markets.
Minimum 4 years of people management experience in a regulatory or scientific environment.
Why Join Apotex
Global Exposure: Work across multiple international markets with high-impact projects.
Career Growth: Opportunities for leadership, professional development, and regulatory expertise expansion.
Inclusive Work Environment: Supportive, accessible, and collaborative culture.
Impact: Contribute to regulatory strategies that bring affordable, high-quality medicines to millions of patients globally.
Apply now on thepharmadaily.com to join Apotex as an Assistant Manager – Global Regulatory Affairs and elevate your career in regulatory leadership and global pharmaceutical operations.
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