Executive- Regulatory Affairs PLCM

6 months ago

Mumbai, India Apotex Full time

About Apotex Inc.

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
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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.

Job Requirements

Education: A Post-graduate/Graduate degree in Chemistry/ Pharmacy/ Life Sciences. Knowledge, Skills and Abilities: Candidate should have knowledge about Post-approval change submission requirement and compilation of variation packages for US/CAN/EU/AUS-NZ/ROW markets. Experience: Candidate should have minimum 3 years of experience in US/CAN/EU/AUS-NZ/ROW markets.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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