Scientific Leader, Analytical Product Life Cycle Mgmt/Method Life Cycle Mgmt

Company Overview

Apotex is a Canadian‑based global health company that improves everyday access to affordable, innovative medicines and health products worldwide. With a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products, Apotex is headquartered in Toronto and operates regional offices in the United States, Mexico and India. It is the largest Canadian‑based pharmaceutical company and a preferred partner for the Americas in pharmaceutical licensing and product acquisitions.

Job Summary

The Regulatory Affairs Submissions Lead is responsible for issuing and reviewing global regulatory submission documents, including raw material evaluation, synthetic route comparison, supplier‑driven evaluation, and the development and establishment of specifications for drug substances, drug products and excipients. The role also closes validation gaps under the MLCM program, performs comprehensive testing ...