Global Regulatory Affairs Manager CMC - Remote (based in Quebec or Toronto)

Alphanumeric Systems; Montreal; Remote; CAD 60,000 - 80,000; Part time

Job summary

A leading pharmaceutical company is looking for a Global Regulatory Affairs Manager CMC to work remotely. Candidates must be bilingual in French and English and have over 3 years of experience. The role involves managing global regulatory activities and developing CMC strategies. The position offers a competitive salary of $65-80 CA$/hour and the possibility of contract renewal, with preference for candidates based in Montreal.

Qualifications

• Fluent in both English and French.
• A minimum of 3 years in similar roles.
• Bachelor's degree required, master's preferred in relevant fields.

Responsibilities

• Manage global CMC regulatory activities for assigned projects.
• Develop CMC strategy for submission documents.
• Advise on regulations and procedures for medicinal products.

Skills

Fluent in English and French

3+ years of experience in similar roles

Knowledge of regulatory procedures

Experience in CMC regulatory affairs

Project management skills

Education

Bachelor's degree

Master's degree (preferred)

Tools

Knowledge of ICH guidelines

Knowledge of Veeva vault

Job description

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 role
• Employment: Contractor
• Duration: 1 year with potential for renewal
• Working 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 required
• Preference for people based in the area of Montreal, QC, due to the proximity to the manufacturing site
• Mandatory to be based in Canada with valid documentation (PR or valid Work Permit + valid SIN)

Requirements:

• Fluent in English and French
• 3+ years of experience at a minimum in similar roles
• Bachelor'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 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 and change control process
• Knowledge of ICH guidelines, pharmaceutical and biological files
• Knowledge of Veeva vault also a bonus

Essential 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.