Job Opportunity: Executive – Global Regulatory Affairs at Apotex
Summary:
Apotex, a leading global pharmaceutical company, is seeking a highly motivated and experienced Executive to join our Global Regulatory Affairs team in Mumbai, India. This role offers an exciting opportunity to contribute to the lifecycle management of our products across key global markets, including the US, Canada, EU, and Australia/New Zealand. If you possess a strong understanding of post-approval submissions and a passion for regulatory compliance, we encourage you to apply.
About Apotex:
Apotex is a global healthcare company committed to providing access to high-quality, affordable medicines for patients worldwide. With a presence in over 75 countries, we are dedicated to innovation, excellence, and making a positive impact on global health.
Job Description:
We are currently seeking an Executive – Global Regulatory Affairs to join our team in Mumbai. The successful candidate will play a crucial role in ensuring the timely and compliant registration and maintenance of our pharmaceutical products in various global markets.
Key Responsibilities:
- Prepare, review, and submit Post-Approval Lifecycle Management (PLCM) submissions for the US and Canada.
- Ensure timely regulatory approvals of assigned submissions, meeting deadlines and quality standards.
- Compile and address regulatory agency deficiencies promptly and effectively.
- Prepare post-approval supplements and variation packages in accordance with regulatory requirements.
- Support regulatory compliance activities across US, Canada, EU, and Australia/New Zealand markets.
- Review change control documents and provide comprehensive regulatory assessments.
- Coordinate with internal teams (e.g., manufacturing, quality, R&D) and third-party manufacturers to gather required documentation for submissions.
- Maintain accurate regulatory trackers, databases, and documentation systems.
- Draft and update Standard Operating Procedures (SOPs) and regulatory guidelines as needed.
- Provide support and guidance to team members as required, ensuring timely submission of deliverables.
- Stay abreast of changes in regulatory requirements and guidelines in relevant markets.
Qualifications & Eligibility:
- Education: Graduate or Post-Graduate degree in Pharmacy, Chemistry, or Life Sciences.
- Experience: Minimum 3 years of relevant experience in regulatory affairs, specifically within US, Canada, EU, and Australia/New Zealand regulatory markets.
Skills & Competencies:
- Thorough knowledge of post-approval regulatory submissions and variation filing requirements.
- Strong understanding of pharmaceutical regulatory guidelines and SOPs.
- Excellent documentation, communication (written and verbal), and coordination skills.
- Proven ability to manage multiple submission timelines and prioritize tasks effectively.
- Detail-oriented with a commitment to accuracy and compliance.
- Ability to work both independently and collaboratively within a team environment.
- Proficiency in using regulatory databases and documentation systems.
Why Join Apotex?
- Global Impact: Contribute to a company that is making a difference in global healthcare by providing affordable medicines to patients in need.
- Career Growth: Opportunity to work with a leading pharmaceutical organization and gain valuable experience in global regulatory affairs.
- Meaningful Work: Play a critical role in product lifecycle management and ensuring regulatory compliance.
- Collaborative Culture: Work in a dynamic and collaborative environment with a team of experienced professionals.
- Competitive Benefits: We offer a competitive salary and benefits package.
Job Highlights:
| Category | Details |
|---|---|
| Job Role | Executive – Global Regulatory Affairs |
| Company | Apotex |
| Location | Mumbai, Maharashtra, India |
| Work Type | Full-Time |
| Experience Required | Minimum 3 years |
| Salary (Estimated Range) | ₹6,50,000 – ₹12,00,000 per annum |
Salary range included for informational purposes. Actual compensation may vary based on experience and qualifications.
How to Apply:
If you are a highly motivated individual with a passion for regulatory affairs and a desire to contribute to a leading global pharmaceutical company, we encourage you to apply. Please submit your resume and cover letter through our careers portal. We look forward to hearing from you!