Apotex is recruiting for two positions in Mumbai, Maharashtra: Senior Analyst – Product Life Cycle Management and Executive, Regulatory Affairs NPD US & Canada. The openings focus on regulatory submissions, product life-cycle management, new product development, regulatory documentation, and compliance for pharmaceutical products in international markets.
Candidates with graduate or postgraduate degrees in Pharmacy, Chemistry, Life Sciences, Biology, or related disciplines can review the eligibility requirements for these Apotex jobs.
Job Details
| Particulars | Details |
|---|---|
| Company | Apotex |
| Industry | Pharmaceutical |
| Location | Mumbai, Maharashtra, India – 400079 |
| Number of Positions | 2 |
| Posting Date | October 16, 2026 |
| Job Categories | Regulatory Affairs, Product Life Cycle Management, New Product Development |
Positions Available at Apotex
1. Senior Analyst – Product Life Cycle Management
Location: Mumbai, Maharashtra
Responsibilities
- Prepare and review regulatory product life-cycle management (PLCM) submissions for the US and Canada.
- Support new product development submissions and prepare pre- and post-approval supplements.
- Maintain regulatory documentation, databases, trackers, and submission records.
- Assess change-control documents and review change-control forms.
- Coordinate with third-party manufacturers to obtain documentation required for regulatory submissions.
- Follow up with internal departments to compile submissions and responses to regulatory queries.
- Ensure compliance with standard operating procedures (SOPs), regulatory policies, procedures, and guidelines.
- Coordinate with internal departments, agents, and suppliers to resolve regulatory issues and obtain submission-related information.
Eligibility and Qualifications
- Graduate or postgraduate degree in Chemistry, Pharmacy, or Life Sciences.
- Minimum one year of experience in US, Canada, EU, or Australia–New Zealand markets.
- Knowledge of pre- and post-approval change submission requirements.
- Experience compiling new dossiers and variation packages for US, Canada, EU, or Australia–New Zealand markets.
2. Executive, Regulatory Affairs NPD US & Canada
Location: Mumbai, Maharashtra
Responsibilities
- Prepare and review regulatory new product development (NPD) submissions for injectable and sterile dosage-form products in the US and Canada.
- Prepare deficiency responses and review quality documents for regulatory submissions.
- Maintain regulatory documentation, databases, submission spreadsheets, and deficiency trackers.
- Assess change-control documents and coordinate corrective information for submissions.
- Coordinate with third-party manufacturers for regulatory documentation.
- Work with cross-functional departments to resolve regulatory submission issues.
- Follow up with relevant teams to compile and file submissions and regulatory query responses.
- Ensure compliance with SOPs, regulatory policies, procedures, and guidelines.
- Coordinate regulatory affairs projects as assigned.
Eligibility and Qualifications
- Graduate or postgraduate degree in Chemistry, Biology, Pharmacy, Health Sciences, or a similar discipline.
- Project Management qualifications or knowledge are an additional advantage.
- Four to seven years of core regulatory affairs experience in the US, Canada, and/or EU.
- Demonstrated knowledge of generic new product development and dossier compilation for sterile injectable products in key markets, including the US, Canada, and EU.
- Understanding of technical, quality compliance, and global regulatory requirements.
Required Skills
Depending on the position, candidates should have relevant knowledge and skills in:
- Regulatory submissions and product life-cycle management.
- New product development dossiers and variation packages.
- Pre- and post-approval regulatory changes.
- Regulatory documentation, deficiency responses, and database maintenance.
- SOPs, regulatory guidelines, and quality compliance.
- Coordination with cross-functional teams, manufacturers, agents, and suppliers.
- Microsoft Office, particularly Word and Excel; MS Project or other project management software is relevant to the Executive position.
- Communication, presentation, and interpersonal skills.
Overall Qualifications
Graduate or postgraduate degree in Pharmacy, Chemistry, Life Sciences, Biology, Health Sciences, or a related discipline, depending on the position.
Overall Experience
1–7 years, depending on the position: minimum one year in relevant international markets for the Senior Analyst role and four to seven years of core regulatory affairs experience for the Executive role.
