Global Regulatory Affairs Manager CMC (Pharmaceuticals) - Remote (Toronto or Montreal)

About the position reputed company is hiring a Global Regulatory Affairs Manager CMC (Pharmaceuticals) to work remotely in Quebec or Ontario for one of the biggest Pharmaceutical companies in the world, based in Montreal, Quebec. Preference for candidates near Montreal due to the proximity to the HQ, as some occasional on-site reputed company might be required. This position must master English language skills verbally and written because it reports to stakeholders, managers and clients reputed company of Quebec where the environment requires communications in English. Please be reputed company that we can only hire people already based in Canada with fully reputed company and reputed company documentation to work in Canada. Responsibilities • Responsible for the global CMC regulatory activities for assigned reputed company and responds readily to changing events and priorities. • Responsible for CMC reputed company development, with managerial support, for CMC submission documents to support marketed product lifecycle management activities in accordance with the applicable regulatory & scientific standards. • Understands, interprets, and will sometimes advise teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, review and approval of global CMC applications. • Ensures reputed company appropriate CMC regulatory aspects for product release are in reputed company, to ensure continuity of market supply. • Ensures information submitted lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/reputed company flexibility with minimal unanticipated questions. Requirements • Bachelors degree is required, masters degree is highly preferred • 3+ years of experience at a minimum • Bilingual English/French • Knowledge of regulatory procedures/systems/guidance’s and technical regulatory life cycle management • Knowledge of biological products • Experience in CMC regulatory affairs/technical life cycle management, preferably with biological/vaccines, proven ability to manage typical regulatory activities, etc. • Experience in CMC authoring of CMC technical variations and Module 3 components • Experience in project management • Experience in change control process • Knowledge of ICH guidelines, pharmaceutical and biological files • Must be based in Canada with reputed company documentation (PR or reputed company Work Permit + reputed company SIN) • Master English language skills verbally and written reputed company-to-haves • Knowledge of reputed company vault also a bonus Benefits • Salary : 61 CA$/hour Apply tot his job Apply To this Job