Regulatory Affairs Consultant – CMC plasma products (home or office based)

Overview

In this role you drive post-approval regulatory activities for CMC in biological and plasma products, ensuring worldwide submissions stay compliant. You will partner with manufacturing, QA, QC, and other regulatory functions to shape submission strategies and manage change controls across global markets. Your work supports variations, renewals, market expansions, and annual reports, helping bring therapies to patients efficiently. You will thrive in a collaborative, client-focused environment that values empathy, accountability, and domain expertise. This opportunity offers travel-flexible, remote-ready work across multiple European locations and a chance to influence global regulatory paths

Responsibilities

• Develop submission strategies and plans for post-approval CMC activities (variations, renewals, market expansions, annual reports)
• Assess change controls and provide regulatory assessments of quality changes in production and quality control
• Review study reports from QC and production to ensure regulatory compliance
• Coordinate submission preparation with manufacturing, supply chain, QC, QA, and other regulatory departments
• Write/review submission content to align with regulatory requirements for variations and health authority questions
• Manage projects within Regulatory Information Management systems and maintain worldwide submissions
• Identify, escalate, and mitigate risks in regulatory procedures and activities
• Ensure awareness of plasma product processes and related regulatory expectations

Key requirements

• University-level education, preferably Life Sciences, or equivalent by experience
• Experience in regulatory affairs focused on technical/CMC/quality in the pharmaceutical industry
• Strong understanding of CMC and post-approval regulatory requirements
• Experience writing CMC (technical) sections for registration files or variations
• Knowledge of plasma products processes
• Background in validation/QA/production with regulatory documentation experience
• Understanding of qualification/validation principles
• Proficiency with Word, PowerPoint, Excel; experience with Veeva Vault is valued
• Team spirit, flexibility, accountability, and organizational skills
• Fluent in English (written and spoken)

• team spirit
• flexibility
• accountability
• CMC regulatory knowledge
• post-approval regulatory submissions
• regulatory writing for CMC

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