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Apotex, a leading Canadian-based pharmaceutical company, is hiring a Senior Analyst – Global Regulatory Affairs in Mumbai, Maharashtra. This role is ideal for professionals with expertise in US and Canadian regulatory submissions, product lifecycle management, and compliance. Join Apotex and contribute to making innovative and affordable medicines accessible worldwide.
Key Responsibilities
- Prepare and review pre and post-approval submissions for US and Canadian markets.
- Support new product development (NPD) submissions ensuring timely approvals.
- Maintain regulatory documentation, databases, and trackers to ensure accuracy.
- Assess change control documents and provide accurate evaluations for submission.
- Coordinate with third-party manufacturers for document requirements.
- Draft or interpret SOPs, RA policies, and regulatory guidelines.
- Communicate effectively with internal teams and external stakeholders (agents, suppliers) to resolve regulatory issues.
- Serve as a backup for team members and support cross-functional regulatory activities.
- Ensure compliance with global quality, safety, and HR policies.
Qualifications
- Graduate/Post-graduate in Pharmacy, Chemistry, or Life Sciences.
- Minimum 1 year of experience in US/CAN/EU/AUS-NZ markets regulatory affairs.
- Strong knowledge of pre and post-approval changes, dossier preparation, and regulatory compliance.
- Excellent communication, coordination, and documentation skills.
Benefits
- Opportunity to work with a global pharmaceutical leader.
- Exposure to US and Canadian regulatory processes.
- Collaborative and inclusive work culture.
- Compliance-friendly environment with support for applicants with disabilities.
How to Apply
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