3 Ectd Format Jobs

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . 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 Postgraduate/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 a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer 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. Show more Show less

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. 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 Postgraduate/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 a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer 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. Show more Show less

The Regulatory Affairs Senior Associate role involves being responsible for the preparation, compilation, evaluation, and submission of ANDAs & Amendments to USFDA. This position also entails handling deficiencies and ensuring the timely submission of responses to the agency. Your main responsibilities will include coordinating with cross-functional teams and stakeholders such as R&D, Quality, manufacturing, SCM, IP, and PM, along with vendors when necessary. You will be tasked with evaluating documents in accordance with current regulatory requirements. Additionally, you will need to review various documents including Product Development Reports, Batch Records, Specifications, Analytical Procedures, Validation Protocols and Reports, Certificates of Analysis, stability protocols, and reports. You will also be responsible for reviewing vendor documents related to API, Excipients, and Packing materials to ensure adequacy and compliance. Furthermore, you will be involved in the preparation, review, and compilation of ANDAs, Amendments, and Supplements in eCTD format. Collaboration with the Regulatory Operation team member for uploading submissions in eCTD software and reviewing exported submissions for submission will be part of your routine tasks. It is also essential to monitor the FDA website for any updates. To qualify for this role, you should possess a Master of Pharmacy in the Department of Pharmaceutics and have at least 3-5 years of experience in Regulatory Affairs.,