Global Regulatory Affairs Manager CMC (Pharmaceuticals) - Remote (Toronto or Montreal)
About the position Alphanumeric 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 presence might be required. This position must master English language skills verbally and written because it reports to stakeholders, managers and clients outside of Quebec where the environment requires communications in English. Please be aware that we can only hire people already based in Canada with fully legal and valid documentation to work in Canada.
Responsibilities
- Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities.
- Responsible for CMC strategy 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 all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply.
- Ensures information submitted lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality 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 valid documentation (PR or valid Work Permit + valid SIN)
- Master English language skills verbally and written
Nice-to-haves
- Knowledge of Veeva vault also a bonus
Benefits
- Salary : 61 CA$/hour
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