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
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