Regulatory Affairs Manager - CMC biologics (various European locations)

When our values align, there's no limit to what we can achieve.
 


Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager ( Regulatory Affairs Consultant) to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations.

As the CMC Regulatory Manager, you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products.

Primary Tasks & Responsibilities:


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Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.



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Assess change controls and provide regulatory assessments of quality changes in production and quality control.



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Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.



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Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.



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Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.



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Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.



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Identify, escalate, and mitigate risks associated with regulatory procedures and activities.


Experience and Knowledge Requirements:


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University-level education, preferably in Life Sciences, or equivalent by experience.



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Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.



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Strong understanding of CMC and post-approval regulatory requirements.



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Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.



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Knowledge of biological processes.



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Background in validation/ Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles.



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Proficiency in Word, Power Point, Excel, and experience with Veeva Vault is valued.



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Team spirit, flexibility, accountability, and organizational skills.



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Fluent in English (written and spoken). French, Italian and German would be a strong plus.