Apotex, one of Canada’s leading pharmaceutical companies, has announced an excellent career opportunity for Trainee – Regulatory Affairs at its Bangalore office. This is an ideal opportunity for fresh pharmacy graduates and candidates from chemistry or related scientific disciplines looking to build a career in Regulatory Affairs, eCTD submissions, dossier preparation, and global pharmaceutical regulations.
Candidates interested in working with a global pharmaceutical organization supporting US FDA and Health Canada regulatory submissions are encouraged to apply.
About Apotex
Apotex is a Canadian-based global healthcare company committed to improving access to affordable medicines worldwide. With operations across North America, Latin America, India, and other international markets, Apotex develops and manufactures generic medicines, biosimilars, branded pharmaceuticals, and consumer healthcare products.
The company is recognized for its strong regulatory expertise, innovation, and commitment to quality and compliance.
Job Details
| Particular | Details |
|---|---|
| Company | Apotex |
| Position | Trainee – Regulatory Affairs |
| Job Location | Bangalore, Karnataka |
| Experience | 0+ Years |
| Qualification | Bachelor’s or Master’s Degree in Pharmacy, Chemistry, or Related Scientific Discipline |
| Department | Regulatory Affairs |
| Employment Type | Full Time |
Selected candidates will be responsible for:
- Preparing regulatory dossiers for US FDA and Health Canada submissions.
- Supporting new product regulatory submissions and lifecycle management activities.
- Preparing and submitting high-quality eCTD submissions.
- Compiling and maintaining regulatory documentation.
- Coordinating with internal departments for submission documents.
- Managing regulatory databases and submission trackers.
- Responding to regulatory agency deficiency queries.
- Supporting regulatory compliance activities.
- Completing assigned regulatory training programs.
- Collaborating with cross-functional teams.
- Maintaining compliance with global quality, ethics, safety, and HR policies.
Candidates possessing any of the following qualifications are eligible:
- Bachelor of Pharmacy (B.Pharm)
- Master of Pharmacy (M.Pharm)
- Bachelor’s Degree in Chemistry
- Master’s Degree in Chemistry
- Other related Scientific disciplines
Applicants should possess:
- Knowledge of Global Regulatory Guidelines
- Understanding of pharmaceutical products
- Interest in Regulatory Affairs
- Quick learning ability
- Excellent written and verbal communication
- Teamwork and collaboration skills
- Attention to detail
- Documentation skills
- Time management
- Regulatory compliance awareness
- Freshers are eligible
- 0+ Years Experience
This makes the opportunity suitable for recent graduates looking to start a career in pharmaceutical regulatory affairs.
Working at Apotex provides several career advantages:
- Global pharmaceutical exposure
- Hands-on experience in US FDA and Health Canada submissions
- Opportunity to work on eCTD publishing
- Career growth in Regulatory Affairs
- Cross-functional learning
- International regulatory exposure
- Professional training and development
- Inclusive workplace culture
- Stable multinational pharmaceutical organization
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