 Chemistry Analyst Jobs at ApoPharma, Apply Now
Apotex, through its subsidiary ApoPharma, is a global leader in pharmaceutical innovation, dedicated to improving the quality of life for patients with severe and life-threatening diseases. With a strong focus on drug development and regulatory excellence, Apotex is seeking a Senior Analyst, GBS GRA PLCM for its Mumbai location. This role presents a dynamic opportunity to contribute to product life-cycle management (PLCM), regulatory submissions, and global compliance within a collaborative, values-driven environment.
About Apotex
ApoPharma, part of the Apotex group of companies, is committed to the discovery, development, and delivery of innovative medicines that address debilitating and life-threatening diseases. One of its primary research areas is understanding the role of iron in human disease and developing novel drugs to treat such conditions.
Job Summary
Apotex is hiring a Senior Analyst, GBS GRA PLCM in Mumbai. The role is responsible for managing the product life cycle of Apotex products in designated markets, maintaining accurate regulatory documentation, and ensuring timely submission and approval in line with global standards.
Key Responsibilities
- Prepare high-quality post-launch PLCM packages to ensure timely approvals.
- Maintain and complete regulatory documents to support compliance across global markets.
- Assess, coordinate, and compile deficiency responses in a timely manner.
- Collaborate with cross-functional teams to resolve regulatory submission issues.
- Prepare and evaluate post-approval supplements to manage product life cycles.
- Review change control documents and provide accurate assessments.
- Maintain regulatory databases and trackers to ensure accuracy.
- Coordinate with third-party manufacturers for regulatory documentation.
- Provide timely communication and follow-up with internal teams for PLCM submissions.
- Draft SOPs and ensure adherence to regulatory policies and global compliance guidelines.
- Act as a backup for team members when needed, supporting collaborative outcomes.
- Communicate with external stakeholders, such as agents and suppliers, for data collection purposes.
Job Requirements
- Education: Graduate or Post-graduate in Chemistry, Pharmacy, or Life Sciences.
- Experience: Minimum 1 year in regulatory affairs, handling submissions for US, Canada, EU, Australia–New Zealand, or Rest of World (ROW) markets.
- Skills: Strong knowledge of post-approval change submission requirements, regulatory variation package compilation, and compliance procedures.
Work Environment & Values
Apotex fosters an inclusive and accessible workplace where employees are valued and supported. The company is guided by its values of Collaboration, Courage, Perseverance, and Passion. Accommodations are available for applicants with disabilities throughout the recruitment process.
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