Lead Executive – New Product Development, Regulatory Intelligence

Apotex Inc.

Lead Executive managing new product development and regulatory intelligence at Apotex, a Canadian-based global health company. Overseeing registration applications for international markets including Europe and Asia.

Posted 5/19/2026full-timeMumbai • 🇮🇳 IndiaSeniorWebsite

About the role

Key responsibilities & impact

Compilation and submission of new registration applications, deficiency responses and pre-launch variations for assigned products in international markets.
Maintenance of documentation/database records pertaining to products, in line with systems, processes and procedures.
Handling of change control review (CCR) related activities like confirmation on change assessment, document verification and closing of RA approval tracker.
Supporting and/or coordinating regulatory affairs projects, as assigned.
Preparation of submission and approval notifications for new product applications submitted to Regulatory agencies.
Review applications to ensure one cycle approval.
Support leaders in developing robust processes and systems to build high quality applications and reduce deficiencies from health agencies.
Support Global Project Management team on activities related to project planning and execution.

Requirements

What you’ll need

A Graduate/ Post graduate degree in Chemistry, Biology, Pharmacy, Health Sciences or similar.
Project Management would be additional advantage.
Demonstrated knowledge of the generic new product development process/requirements and compilation of dossier for key international markets such as Europe, GCC-MENA, Australia, New Zealand, LATAM, Mexico, Brazil, Singapore and Malaysia.
Must possess knowledge of the technical, quality compliance, and global regulatory requirements.
Excellent communication, presentation, and interpersonal skills.
Demonstrated experience in influencing & coordinating the complex regulatory activities and interaction with cross-functional teams & stakeholders.
Excellent understanding of Project Management principles and practice in a complex environment.
Excellent oral/written communication in English.
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).
Candidate should have minimum 7 years of experience in Europe, GCC-MENA, Australia, New Zealand, LATAM, Mexico, Brazil, Singapore and Malaysia market.

Benefits

Comp & perks

Accommodation provided for applicants with disabilities as part of the recruitment process

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

new product development processdossier compilationregulatory requirementschange control reviewdocumentation maintenanceproject planningproject executionquality complianceregulatory affairsdeficiency response

Soft Skills

communication skillspresentation skillsinterpersonal skillsinfluencing skillscoordination skillscross-functional teamworkstakeholder interactionprocess developmentproblem-solvingorganizational skills