Lead Executive – Global Regulatory Affairs
Location: Mumbai, Maharashtra, India
Work Type: Full-Time
Company: Apotex Inc.
Date Posted: 30 January 2026
About Apotex Inc.
Apotex Inc., headquartered in Canada, is a global healthcare company dedicated to producing high-quality, affordable medicines for patients worldwide. With a workforce of over 7,200 employees, Apotex operates in manufacturing, R&D, and commercial domains. Our medicines are accessible in 75+ countries, and the organization focuses on generic, biosimilar, and specialty products through vertical integration. For more information, visit www.apotex.com.
Role Overview
The Lead Executive – Global Regulatory Affairs will drive product life-cycle management (PLCM) for Apotex products across multiple markets, including US, Canada, EU, Australia, New Zealand, and ROW (Rest of World). This role involves regulatory submissions, post-approval changes, documentation management, and providing regulatory guidance to the team. You will collaborate with cross-functional teams, third-party manufacturers, and regulatory agencies to ensure compliance and timely approvals.
Key Responsibilities
Lead and coordinate regulatory affairs projects, ensuring completion within timelines and quality standards.
Prepare, review, and submit regulatory dossiers, post-approval change packages, and deficiency responses for US, CAN, EU, AUS-NZ, and ROW markets.
Maintain regulatory documentation and databases, including trackers for PLCM submissions, deficiency responses, and submission spreadsheets.
Collaborate with R&D, QA, QC, Production, and third-party manufacturers to gather and review technical documents for submissions.
Interpret and ensure compliance with SOPs, RA policies, and global regulatory guidelines. Draft SOPs and guidelines as required.
Provide regulatory guidance and mentorship to team members; support training programs for new employees.
Act as a backup for team members, ensuring uninterrupted regulatory operations.
Communicate effectively with external stakeholders such as agents and suppliers for timely provision of submission data.
Resolve complex regulatory issues, propose solutions, and execute strategic regulatory actions for complex submissions.
Contribute to a culture of collaboration, integrity, and compliance, promoting teamwork and empowerment within the department.
Required Qualifications & Experience
Education: Graduate or Postgraduate degree in Pharmacy, Chemistry, or Life Sciences.
Experience: Minimum 7 years of experience in regulatory affairs across US, CAN, EU, AUS-NZ, or ROW markets.
Proven expertise in post-approval changes, variations, and dossier submissions for global markets.
Strong knowledge of regulatory requirements and compliance standards across multiple regions.
Experience in working with cross-functional teams, regulatory agencies, and third-party manufacturers.
Skills & Competencies
Excellent project management and organizational skills for global regulatory submissions.
Strong analytical, problem-solving, and decision-making abilities.
Effective stakeholder management and team leadership capabilities.
Superior written and verbal communication skills in English.
Proficiency in MS Office, regulatory databases, and submission tracking tools.
Ability to interpret complex regulatory guidelines and provide actionable strategies.
Self-motivated, detail-oriented, and capable of working independently or collaboratively.
Why Join Apotex
Be part of a global healthcare company delivering affordable, high-quality medicines worldwide.
Gain exposure to regulatory submissions and product lifecycle management across multiple international markets.
Collaborate with cross-functional teams and global regulatory professionals.
Competitive compensation, professional development opportunities, and a supportive, inclusive workplace.
Apply Now on thepharmadaily.com to join Apotex as a Lead Executive in Global Regulatory Affairs and advance your career in international pharmaceutical regulatory management.
Gujarat :
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