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Apotex Regulatory Affairs Executive Job – NPD US & Canada in Mumbai
Published on: October 19, 2026
Apotex has listed an opening for Executive, Regulatory Affairs NPD US & Canada in Mumbai, Maharashtra. The position is intended for regulatory affairs professionals with 4–7 years of core experience and knowledge of new product development and regulatory submissions for sterile injectable products.
Practice your pharmaceutical knowledge with our Free Pharma Mock Tests. You can also explore Regulatory Affairs Jobs and our guide to a Career in Regulatory Affairs After B.Pharm for more career resources.
1. Apotex Job Details
| Particulars | Details |
|---|---|
| Company | Apotex |
| Job Title | Executive, Regulatory Affairs NPD US & Canada |
| Location | Mumbai, Maharashtra, India |
| Qualification | Graduate or postgraduate degree in Chemistry, Biology, Pharmacy, Health Sciences or a similar field |
| Experience | 4–7 years in core Regulatory Affairs |
| Relevant Markets | US, Canada and/or EU |
| Product Focus | Sterile injectable products |
| Posting Date | October 16, 2026 |
| Application Mode | Online |
| Salary | Not specified in the listing |
| Official Application | View Job Details & Apply |
Official Source: This vacancy is based on the job listing published on the Apotex Careers website. Refer to the official listing for the latest requirements and application status.
2. About Apotex
Apotex is a Canadian-based global health company that develops and supplies generic medicines, biosimilars, branded pharmaceuticals and consumer health products. Its headquarters are in Toronto, Canada, and it operates internationally, including in India.
This role supports regulatory activities for new product development, with a focus on submissions and quality documentation for sterile injectable products.
3. Key Responsibilities
| Area | Main Responsibilities |
|---|---|
| Regulatory submissions | Prepare and review new product development submissions for the US and Canadian markets |
| Deficiency responses | Compile responses to regulatory deficiencies and coordinate agency queries |
| Quality documentation | Review documents required for submissions and maintain approved product records |
| Change control | Assess change-control documents for regulatory impact, as assigned |
| Databases and trackers | Maintain regulatory databases, submission spreadsheets and deficiency trackers |
| Coordination | Work with internal teams, third-party manufacturers, agents and suppliers to obtain required information |
| Compliance | Follow applicable SOPs, regulatory guidelines and company policies |
| Project support | Coordinate regulatory projects and help resolve submission-related issues |
The role requires accurate documentation, effective communication and timely coordination to support regulatory submissions.
4. Eligibility Criteria
4.1 Education and Experience
| Requirement | Details |
|---|---|
| Education | Graduate or postgraduate degree in Chemistry, Biology, Pharmacy, Health Sciences or a similar discipline |
| Experience | 4–7 years in core Regulatory Affairs |
| Regulatory knowledge | Generic new product development and dossier compilation for sterile injectables |
| Market knowledge | US, Canada and/or EU regulatory requirements |
| Communication | Strong written and verbal English skills |
| Software | Microsoft Word, Excel and Project, or other project management software |
| Additional advantage | Project management knowledge |
Candidates should have a sound understanding of technical documentation, quality compliance and global regulatory requirements. The listing specifies experience in the US, Canada and/or EU; it does not state that experience in all three markets is mandatory.
5. Is This Role a Good Fit for You?
This position may be suitable for Regulatory Affairs professionals who have practical experience with:
- Preparing or reviewing regulatory submission documents for new product development.
- Working with technical documentation for sterile injectable products.
- Coordinating responses to regulatory deficiencies and agency queries.
- Assessing regulatory documentation for proposed product or manufacturing changes.
- Following up with Quality Assurance, R&D and other teams to collect submission-related information.
Before applying, compare your experience with the responsibilities listed in the official Apotex vacancy. Highlight relevant projects and technical skills in your CV, and avoid claiming experience you do not have.
6. How to Apply
Candidates can review the full requirements and submit an application through the official company careers portal.
Apply for Executive, Regulatory Affairs NPD US & Can – Mumbai
Before applying, check that the vacancy is still available and that your experience aligns with the listed responsibilities.
CV tip: Highlight relevant experience with regulatory submissions, sterile injectable dossiers, deficiency responses, change-control assessments and cross-functional coordination. Include only skills and responsibilities that reflect your actual work.
7. Frequently Asked Questions
7.1 What is the location of this Apotex job?
The position is listed in Mumbai, Maharashtra, India.
7.2 Is sterile injectable experience relevant?
Yes. The role specifically involves regulatory submissions and quality documentation for sterile injectable products.
7.3 Does Apotex provide recruitment accommodations?
Yes. The company states that accommodations are available for applicants with disabilities. Candidates who require assistance should inform Apotex when contacted to arrange an interview or test.
8. Disclaimer
PharmaCareerUpdates.com is an independent pharmaceutical career information website and is not affiliated with, endorsed by or officially associated with Apotex. Candidates should verify the latest vacancy status, eligibility requirements and application details on the official company website before applying.
