Company: Apotex Inc.
Location: Bangalore
Industry: Pharmaceutical / Healthcare / Clinical Research
Application Deadline: 30th October 2024
Company Overview
Apotex Inc. is a proud Canadian global pharmaceutical company dedicated to producing high-quality, affordable medicines for patients worldwide. With nearly 8,000 employees across more than 100 countries, we operate through various divisions and affiliates, including Apobiologix for biosimilar development and Aveva.
Job Summary
We are seeking a Senior Executive in Regulatory Affairs to oversee the preparation and submission of Drug Master Files (DMF) and ensure compliance with regulatory guidelines across various markets, including the US, EU, TGA, and Canada.
Key Responsibilities
- DMF Preparation & Submission: Compile, review, and submit original DMFs, amendments, and annual reports in line with regulatory requirements.
- Coordination: Work closely with technology transfer sites to provide regulatory support for DMF and dossiers.
- Regulatory Tools Execution: Utilize tools like Docubridge, Livelink, RIMS, Trackwise, and Label Bridge for regulatory activities.
- Deficiency Responses: Compile and review responses for regulatory deficiencies.
- Documentation Review: Evaluate draft RSM, MPDR, and GTI discussions concerning current processes and screening study data.
- Change Control Assessment: Conduct risk assessments of DMFs for regulatory impact prior to implementation.
- Business Development Support: Assist with regulatory aspects related to third-party customers.
- Cross-Department Collaboration: Interact with R&D, QC, QA, production, and AR&D teams regarding RA issues for DMF submissions.
- Administrative Duties: Handle local licensing activities and other administrative tasks related to regulatory affairs.
Candidate Profile
- Education: Master’s degree in Science or Pharmacy (M.Pharm, MSc).
- Experience: 6-8 years in Regulatory Affairs, specifically related to APIs.
- Skills:
- Proficient in MS Office (Word, PowerPoint, Excel).
- Strong communication skills for interaction with various departments.
How to Apply
If you are ready to contribute to a company that values innovation and quality in healthcare, please submit your resume and cover letter by 30th October 2024.
Join Apotex Inc. and be a part of our mission to improve the health of patients around the world!a
