Regulatory Affairs Manager - New Product Development International

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 SummaryLeads a team responsible for new product registrations and lifecycle management across global markets, including LATAM, APAC, Caribbean, EMEA, GCC, EU, and ANZ. Oversees dossier compilation, review, submissions, deficiency responses, and pre-launch regulatory activities to support successful product approvals and launches. Partners closely with R&D, Quality, Operations, and regional affiliates to prioritize and track regulatory deliverables, ensure compliance with global regulatory requirements, and maintain data integrity across regulatory systems. Additionally, drives process improvement initiatives, supports implementation of new regulatory practices, and develops team capability through technical guidance, coaching, and performance leadership.

Key Responsibilities / Profile HighlightsExtensive hands-on expertise in CMC regulatory affairs supporting new product registrations across global markets, including European Union (EU), GCC, LATAM, APAC (including Australia & New Zealand), and Caribbean regions.Lead dossier compilation, review, and submission activities for new product registrations, ensuring compliance with country-specific and international regulatory requirements.Manage and coordinate responses to health authority deficiencies, queries, and information requests, driving successful product approvals and timely market launches.Provide regulatory strategic support throughout the product development lifecycle, ensuring alignment with evolving global regulatory expectations.Partner closely with R&D, Quality, Manufacturing/Operations, Supply Chain, and Regional Regulatory Teams to prioritize, coordinate, and track critical regulatory deliverables.Provide technical leadership and mentorship to regulatory team members through coaching, training, and knowledge-sharing initiatives.

Job RequirementsEducationA Graduate/ Post graduate degree in Pharmacy.

Knowledge, Skills and AbilitiesMust possess detailed knowledge of the technical, quality compliance, and global regulatory requirements.Excellent oral/written communication in English.Excellent communication, presentation, and interpersonal skills.Excellent Leadership, negotiation, problem-solving and conflict management skills.Demonstrated experience in supervising, influencing, and coordinating the complex activities and interaction of staff, including direct and non-direct reports.Strong organisational skills; ability to work independently as well as in dynamic team environment.Strong ability to lead a team of professionals.Demonstrated knowledge of the generic new product development and post approval management process.Excellent understanding of Project Management principles and practice in a complex environment.Knowledge of recent updated Guidance’s of Health agencies is a must.Knowledge of and experience with the MS-Office suite of products; with particular emphasis on MS-Word, MS-Excel, and MS-Project (or other PM software).Should be a Subject Matter Expert (SME) for NPD dossiers of international markets.

Experience15+ years’ progressive experience pharmaceutical industry.10+ years’ regulatory filing experience with exposure to new product registration & compliance activities for Finished Dosage forms.Candidate should have knowledge about NPD submission requirement and compilation of dossier for international markets. Expertise in LATAM and/or EMEA would be an added advantage.

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.