Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc.
Post : Trainee, Regulatory Affairs PLCM
Job Summary
• Collation, compilation and dispatch/submission of regulatory documentation for assigned projects.
• Maintenance of documentation/database records pertaining to products, in line with systems, processes and procedures.
• Supporting and/or coordinating regulatory affairs projects (especially tender projects), as assigned.
Job Responsibilities
• Collation, compilation and timely dispatch of required regulatory documentation to Apotex affiliates/customer and follow-up on timely submission of applications to the health authority.
• Timely communication and follow up with the respective departments for compilation of tender submissions and for database updates
• Responsible to respond to queries received from Apotex affiliates/customer and health regulatory agencies on regulatory submissions.
• Maintain records in global regulatory databases, update established trackers & status sheets and ensure accuracy of information.
• Adherence to the responsibilities as assigned, act as a back-up for team members and support other projects as & when assigned.
• Completion of all the assigned trainings in timely manner.
• Contributes towards the creation and promotion of an environment of teamwork and empowerment built on mutual trust and respect.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.
Candidate Profile
• A Graduate/ Post graduate in Pharmacy.
• Knowledge, Skills and Abilities:
• Candidate should have good academic background. Knowledge about New Product Dossier and PLCM submission requirements will be an additional advantage.
• Should have 0-1 years of regulatory affairs experience in International markets.
Additional Information
Experience : 0-1 years
Qualification : B.Pharm, M.Pharm
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs PLCM
End Date : 30th June 2024
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