Latest Pharma Job Vacancies at Apotex | Apply Now for Trainee Regulatory Affairs Position
Are you a Pharmacy graduate or postgraduate eager to launch your career in global pharmaceutical regulatory affairs? ApoPharma, part of the renowned Apotex group, is offering a Trainee position in Mumbai that puts you at the heart of life-changing medicine development. In this role, you’ll gain hands-on experience in compiling and submitting regulatory documentation, supporting international submissions, and contributing to projects that improve patient care worldwide—all while working in a collaborative, growth-focused environment.
About the Company
ApoPharma, part of the Apotex group of companies, is a leading pharmaceutical innovator dedicated to improving lives through groundbreaking research and advanced medicines. With a strong focus on the role of iron in human disease, ApoPharma develops novel treatments for serious and life-threatening conditions. Guided by values of Collaboration, Courage, Perseverance, and Passion, the company is committed to scientific excellence, regulatory compliance, and delivering life-changing therapies to patients worldwide. ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company dedicated to discovering, developing, and providing new medicines that improve the quality of life for patients with debilitating and life-threatening diseases. A major research focus is investigating the
role of iron in human disease and creating novel treatments for conditions caused or worsened by iron.Job Details
- Job Post: Trainee, GBS GRA PLCM-GBS-PLC-GBS-PLCM G
- Location: Mumbai, MH, IN, 400079
- Job Requirements
- Education: Graduate or Postgraduate in Pharmacy.
- Knowledge & Skills: Strong academic background; knowledge of New Product Dossier and PLCM submissions preferred.
- Experience: Theoretical understanding of regulatory affairs for International/US-CAN-EU markets.
Job Summary
- Collation, compilation, and submission of regulatory documentation for assigned projects.
- Maintenance of documentation and database records for products, in line with systems, processes, and procedures.
- Support and coordination of regulatory affairs projects, especially tender projects.
Job Responsibilities
- Compile and dispatch regulatory documentation to Apotex affiliates/customers and follow up on health authority submissions.
- Coordinate with departments to ensure timely tender submissions and database updates.
- Respond to queries from affiliates, customers, and regulatory agencies.
- Maintain accurate records in global regulatory databases and update trackers.
- Act as a backup for team members and support other assigned projects.
- Complete all assigned training promptly.
- Promote teamwork, collaboration, and mutual respect.
- Work safely and adhere to organizational values: Collaboration, Courage, Perseverance, and Passion.
- Comply with all policies, including Ethics, Quality, Safety, Environment, and HR.
- Perform other relevant duties as assigned.
Diversity & Inclusion
ApoPharma is committed to creating an inclusive and accessible work environment where all employees feel valued and supported. Accommodation is available for applicants with disabilities during the recruitment process.
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