Apotex is hiring for the position of Executive – New Product Development in Mumbai, Maharashtra. The role focuses on regulatory affairs for sterile injectable products, including preparation of regulatory submissions, deficiency responses, quality document reviews, and coordination of regulatory activities for the US and Canadian markets.
Candidates with a graduate or postgraduate degree in Pharmacy, Chemistry, Biology, Health Sciences, or a related field and 4–7 years of regulatory affairs experience in the US, Canada, and/or EU markets can apply.
Job Details
| Particulars | Details |
|---|---|
| Company | Apotex |
| Job Title | Executive – New Product Development |
| Department | Regulatory Affairs |
| Location | Mumbai, Maharashtra, India |
| PIN Code | 400079 |
| Job Posting Date | September 23, 2026 |
| Experience | 4–7 years |
| Product Focus | Injectables (Sterile Dosage Forms) |
| Markets | US, Canada, and/or EU |
Position
Executive – New Product Development
The selected candidate will support regulatory affairs activities for new product development, focusing on sterile injectable products and regulatory submissions for the US and Canadian markets.
Job Responsibilities
- Prepare and review regulatory submissions and deficiency responses for sterile injectable products.
- Review quality documents required for regulatory submissions and responses to regulatory deficiencies.
- Compile and coordinate deficiency responses within established timelines.
- Maintain regulatory documentation and databases for approved products.
- Assess change control documents and provide appropriate regulatory assessments.
- Coordinate with cross-functional teams to resolve regulatory submission issues.
- Work with third-party manufacturers to obtain documents required for regulatory submissions.
- Maintain submission spreadsheets, deficiency trackers, review checklists, and other regulatory records.
- Follow up with relevant departments to ensure timely submission filing and query responses.
- Interpret regulatory guidelines and comply with standard operating procedures (SOPs) and regulatory policies.
- Draft SOPs and regulatory guidelines, where applicable.
- Communicate with external agents and suppliers to obtain or provide information relevant to submissions.
- Coordinate regulatory affairs projects and provide team support as required.
Eligibility and Qualifications
Candidates applying for the Apotex Executive – New Product Development position should meet the following requirements:
- Educational Qualification: Graduate or postgraduate degree in Chemistry, Biology, Pharmacy, Health Sciences, or a similar field.
- Experience: 4–7 years of experience in core Regulatory Affairs.
- Market Experience: Experience in the US, Canada, and/or EU regulatory markets.
- Technical Knowledge: Understanding of generic new product development processes and regulatory dossier compilation for sterile injectable products.
Project Management qualifications or knowledge would be an additional advantage.
Required Skills
- Knowledge of global regulatory requirements and quality compliance.
- Understanding of regulatory submissions for sterile injectable products.
- Experience coordinating complex regulatory activities and cross-functional projects.
- Strong communication, presentation, and interpersonal skills.
- Excellent written and spoken English.
- Proficiency in Microsoft Word and Excel.
- Knowledge of Microsoft Project or other project management software.
- Ability to coordinate with internal departments, external agents, suppliers, and third-party manufacturers.
Application Details
- Company: Apotex
- Position: Executive – New Product Development
- Location: Mumbai, Maharashtra, India