Apotex Inc. is a leading Canadian-based 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 operations across 75+ countries. The company specializes in generic, biosimilar, and specialty pharmaceuticals, ensuring accessibility to life-saving medications through vertical integration.
🔗 Website: www.apotex.com
Job Description: Regulatory Affairs Executive – PLCM
Job Summary
The Regulatory Affairs Executive – Product Lifecycle Management (PLCM) will be responsible for managing the regulatory aspects of Apotex products in key global markets (US, Canada, EU, Australia-NZ, and ROW). The role involves maintaining regulatory documentation, preparing submissions, and ensuring compliance with global regulatory standards.
Key Responsibilities
- Prepare and review regulatory submissions (variations, renewals, supplements) for global markets.
- Manage post-approval changes and ensure timely regulatory compliance.
- Coordinate with third-party manufacturers for documentation requirements.
- Maintain regulatory databases and trackers (deficiency responses, submission logs).
- Assess change control documents and provide regulatory impact assessments.
- Support deficiency responses and interact with health authorities as needed.
- Ensure adherence to SOPs, regulatory guidelines, and compliance policies.
- Collaborate with cross-functional teams (QA, R&D, Manufacturing) for regulatory alignment.
- Act as a backup for team members and assist in ad-hoc regulatory tasks.
Job Requirements
Education:
- Postgraduate/Graduate degree in Chemistry/Pharmacy/Life Sciences.
Experience & Skills:
- Minimum 3 years in Regulatory Affairs (PLCM) for US, Canada, EU, Australia-NZ, or ROW markets.
- Strong knowledge of post-approval variation submissions and regulatory guidelines.
- Experience in compiling regulatory dossiers and deficiency responses.
- Familiarity with eCTD submissions and regulatory databases.
- Excellent communication, coordination, and problem-solving skills.
Preferred Skills:
- Knowledge of ICH, FDA, EMA, Health Canada, and TGA regulations.
- Ability to interpret SOPs and regulatory policies.
Why Join Apotex?
✅ Global Impact: Work with a leading pharmaceutical company serving 75+ countries.
✅ Career Growth: Opportunities in Regulatory Affairs, Compliance, and R&D.
✅ Inclusive Work Culture: Apotex promotes diversity, inclusion, and employee well-being.
✅ Compliance & Ethics: Strong adherence to Global Business Ethics, Quality, and Safety policies.
