Lead Executive - New Product Development & Regulatory Intelligence
Apotex Inc. is seeking a Regulatory Affairs Lead to oversee new product development and regulatory intelligence. The role involves managing the compilation and submission of registration applications, ensuring compliance with global standards, and coordinating cross-functional projects. Candidates must have extensive experience in international pharmaceutical markets and strong expertise in eCTD formatting. This position is based in Mumbai and requires deep knowledge of regulatory guidelines and project management.
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Experience
7+ years
Function
Engineering
Work mode
Onsite, India
Company
Tier 2
What you will work on
Apotex Inc. is seeking a Regulatory Affairs Lead to oversee new product development and regulatory intelligence. The role involves managing the compilation and submission of registration applications, ensuring compliance with global standards, and coordinating cross-functional projects. Candidates must have extensive experience in international pharmaceutical markets and strong expertise in eCTD formatting. This position is based in Mumbai and requires deep knowledge of regulatory guidelines and project management.
TAL's take
Solid role at a well-regarded global pharmaceutical company, providing clear ownership in regulatory affairs with a defined international market scope.
The JD is clear and coherent, detailing specific responsibilities for regulatory dossier compilation, project coordination, and compliance for international markets.
Must haves
- 7+ years of core regulatory affairs experience
- Experience in Europe, GCC-MENA, Australia, New Zealand, LATAM markets
- Graduate/Postgraduate degree in Chemistry, Biology, Pharmacy, or Health Sciences
- Knowledge of generic new product development processes
- Proficiency in MS-Office and MS-Project
- Demonstrated knowledge of eCTD format and global regulatory requirements
Tools and skills
Nice to have: cesp.
About the company
Established global pharmaceutical company with a significant international footprint, but not categorized as a major tech-first unicorn or global Tier 1 brand.