Executive, Regulatory Affairs NPD

6 days 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

Compilation and submission of new registration applications, deficiency responses and pre-launch variations for assigned products Maintenance of documentation/database records pertaining to products, in line with systems, processes and procedures Supporting and/or coordinating regulatory affairs projects, as assigned Preparation of submission and approval notifications for new product applications submitted to Regulatory agencies.

Job Responsibilities

Support in review and compilation of applications (i.e., ANDA, Co-dev applications and ANDS) of drug products to Health authorities of US and Canada market. Support in review and compilation of deficiency packages for assigned products of US/Canada market within given timeline & with high quality measured against compiler checklist maintained by team. Review and compilation of New Product applications for international markets as assigned. Building dossier/applications into eCTD format and ensure documents meet strict internal and regulatory standards Ensure dossier/documents are of high-quality standard to ensure one cycle review from Regulatory authorities Support in review and compilation of supplements/pre-launch variations (e.g. CBE, CBE-30, PAS, sANDS and Level -III) for assigned products Maintain records in global regulatory databases and in established trackers (Review checklist for NPD/deficiency response/ pre-launch variation, deficiency tracker, status sheet etc.) and ensure accuracy of information Handling of Common Electronic Submission Gateway (ESG) for submission of applications for US & Canada market In depth (detailed) review of all technical documents required for compilation of New Product Submission (NPD - ANDA/ANDS), Pre-launch variations and query responses before sending it for final review. Completion of all the assigned trainings in timely manner. Actively work to suggest, develop and obtain own Key Performance Measures (KPMs) in conjunction with Reporting Manager Ensure compliance with SOPs and regulatory guidelines published from time to time by respective regulatory agencies Act as a back-up for team members and support as and when required Review of change control forms and provide accurate assessment for change being assessed (as applicable and assigned) Timely communication and follow up with the respective departments for compilation and submission of new product submissions, query responses & pre-launch variation to meet agreed timeline Provides regulatory support to stakeholders as & when required 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 in pharmacy. Knowledge, Skills and Abilities: Candidate should have knowledge about NPD submission requirement and compilation of dossier for US/Canada market. Experience: Candidate should have minimum 3 years of experience in US / Canada market.

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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