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Apotex Inc looking for Regulatory Affairs Executive


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Apotex Inc looking for Regulatory Affairs Executive

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 : Executive - Regulatory Affairs PLCM

Job Description
Job Summary
•  Responsible for the product life-cycle management of Apotex products (Toronto) in identified markets.
•  Maintenance of documentation/database records pertaining to approved products in line with systems, processes and procedures.
•  Leading and/or coordinating regulatory affairs projects, as assigned.
•  Preparation of submission and approval notifications for applications submitted to Regulatory agencies.

Job Responsibilities
•  Responsible for providing support and regulatory guidance to a team in the completion of projects supporting regulatory submissions.
•  Responsible for the preparation and review of quality regulatory PLCM submissions for various markets to ensure timely approval.
•  Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets.
•  Accountable for assessment, coordination and compilation of deficiency responses in a timely manner.
•  Works with other functional areas to resolve issues related to information for regulatory submissions.
•  Evaluate, prepare and review of post-approval supplements to manage the regulatory product life-cycle as applicable.
•  Assessment of change control documents. Review of change control forms and provide accurate assessment for change being assessed (as applicable and assigned).
•  Maintenance of regulatory databases to ensure accuracy of information. Maintain established trackers (Review checklist for PLCM/deficiency response, deficiency tracker, submission spreadsheet etc.) and ensure accuracy of information.
•  Co-ordinate with third party manufacturers for document requirement for regulatory submissions.
•  Act as a back-up for team members and support as & when required.
•  Timely communication and follow-up with the respective departments for compilation and submission of PLCM submissions and query responses to meet agreed timeline.
•  Interpret and ensure compliance with SOPs, RA policies & procedures and regulatory guidelines. Prepare and/or draft SOPs and regulatory guidelines (as applicable).
•  Interact with other applicable departments within Apotex to discuss and provide solutions to regulatory issues and/or problems.
•  Communicate with external sources such as agents and suppliers to request and/or provide data relevant to submissions.
•  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 Post-graduate/Graduate degree in Chemistry/ Pharmacy/ Life Sciences.
•  Candidate should have knowledge about Post-approval change submission requirement and compilation of variation packages for US/CAN/EU/AUS-NZ/ROW markets.
• Candidate should have minimum 3 years of experience in US/CAN/EU/AUS-NZ/ROW markets.

Additional Information
Experience : 3 years
Qualification : M.Pharm, B.Pharm, M.Sc
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 20th April, 2024

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