Job opportunity for Fresher in Regulatory Affairs PLCM at Apotex Inc- Apply before 30th June 2024

Apotex Inc

Website Apotex Inc

About Apotex Inc

Apotex Inc. is a Canadian pharmaceutical corporation that specializes in generic and over-the-counter drugs. Founded in 1974 by Bernard Sherman, it has grown to become one of the largest generic pharmaceutical companies in the world. Apotex develops, manufactures, and distributes a wide range of medications, including those for cardiovascular, central nervous system, and other therapeutic areas. The company operates globally, with facilities in Canada, the United States, Mexico, and several other countries. Apotex has often been noted for its emphasis on affordability and accessibility of medications, particularly in providing cheaper alternatives to brand-name drugs.

Job Opening: Trainee, Regulatory Affairs PLCM

Job Summary

  • Collation, Compilation, and Submission: Handle the gathering, assembling, and submission of regulatory documentation for assigned projects.
  • Documentation Maintenance: Keep product documentation and database records updated, adhering to established systems, processes, and procedures.
  • Project Support and Coordination: Assist in and coordinate regulatory affairs projects, particularly tender projects, as assigned.

Job Responsibilities

  • Documentation Management: Collect, compile, and ensure timely dispatch of regulatory documents to Apotex affiliates/customers. Follow up on the timely submission of applications to health authorities.
  • Interdepartmental Communication: Communicate and follow up with respective departments for tender submissions and database updates.
  • Query Response: Address queries from Apotex affiliates/customers and health regulatory agencies regarding regulatory submissions.
  • Database Management: Maintain records in global regulatory databases, update established trackers and status sheets, and ensure information accuracy.
  • Team Support: Adhere to assigned responsibilities, act as a backup for team members, and support other projects as needed.
  • Training Completion: Complete all assigned training in a timely manner.
  • Team Environment: Contribute to a team-oriented environment that promotes mutual trust and respect.
  • Safety and Collaboration: Work safely and collaboratively to achieve all outcomes.
  • Organizational Values: Demonstrate behaviors that reflect our values: Collaboration, Courage, Perseverance, and Passion.
  • Compliance: Adhere to all compliance programs, including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
  • Additional Duties: Perform other relevant duties as assigned.

Candidate Profile

  • Education: Graduate or Postgraduate in Pharmacy (B.Pharm, M.Pharm).
  • Knowledge and Skills:
    • Strong academic background.
    • Knowledge of New Product Dossier and PLCM submission requirements is an added advantage.
    • 0-1 years of regulatory affairs experience in international markets.

Additional Information

  • Experience: 0-1 years
  • Location: Mumbai
  • Industry Type: Pharma/Healthcare/Clinical Research
  • Functional Area: Regulatory Affairs PLCM
  • Application Deadline: June 30, 2024
  • For more articles, Kindly Click here.
  • For pharmaceutical jobs, follow us on LinkedIn

    For more jobs, kindly visit our job section.

To apply for this job please visit