Global Regulatory Affairs Manager CMC

4 weeks ago

Montreal Toronto Calgary Vancouver Edmonton Old Toronto Ottawa Mississauga Quebec Winnipeg Halifax Saskatoon Burnaby Hamilton Victoria Surrey Halton Hills London Regina Markham Brampton Vaughan Kelowna Laval Southwestern Ontario R, Canada Alphanumeric Systems Full time

Alphanumeric is hiring a Global Regulatory Affairs Manager CMC, to work remotely in Montreal or Toronto with one of the biggest pharmaceutical manufacturing companies in the world.Please be aware that we can only hire people already based in Canada with fully legal and valid documentation to work in Canada. Please apply with your CV in English, as some of the managers might not speak French.Candidates must be fluent in both French and English. This role reports to stakeholders, managers and clients outside of Quebec, where the environment requires communication in English.Conditions:Salary: From 65-80 CA$/hour, depending on experience and fit with the roleEmployment: ContractorDuration: 1 year with potential for renewalWorking Hours: Monday-Friday, 37.5 hours per week on regular business hours (8 AM to 5 PM)Work Location: Remote, however, occasional travel to the Montreal manufacturing site might be requiredPreference for people based in the area of Montreal, QC, due to the proximity to the manufacturing siteMandatory to be based in Canada with valid documentation (PR or valid Work Permit + valid SIN)Requirements:Fluent in English and French3+ years of experience at a minimum in similar rolesBachelor's degree is required, a master's degree is highly preferred (Biotechnology, Biology, Pharmacy, Chemistry, etc)Knowledge of regulatory procedures/systems/guidance’s, and technical regulatory life cycle managementKnowledge of biological productsExperience in CMC regulatory affairs/technical life cycle management, preferably with biological/vaccines, proven ability to manage typical regulatory activities, etcExperience in CMC authoring of CMC technical variations and Module 3 componentsExperience in project management and change control processKnowledge of ICH guidelines, pharmaceutical and biological filesKnowledge of Veeva vault also a bonusEssential Duties and 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. #J-18808-Ljbffr

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