Regulatory Affairs Consultant - CMC biologics (home or office based)
PAREXEL
Industria farmaceutica di ricerca
20095 Milanino, Lombardia - Italien
Specialista Senior / Project Manager
Ibrido
Experteer Overview
In this Regulatory Affairs Consultant role, you will drive post-approval CMC regulatory activities for biological products across Europe, ensuring timely submissions and compliance. You will work closely with manufacturing, QC, QA, and local regulatory teams to coordinate submissions and assess changes. You’ll write and review CMC content, manage Regulatory Information Management systems, and identify regulatory risks to keep global submissions on track. The role offers flexibility between office and home-based work and the chance to contribute to Parexel’s mission of improving patient health.
Responsabilità
- 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 quality control and production for regulatory compliance
- Coordinate submission preparation with manufacturing, supply chain, QC, QA, and other regulatory departments
- Write or review submission content to align with regulatory requirements (variations and questions from health authorities)
- Manage projects within Regulatory Information Management systems and maintain worldwide submissions
- Identify, escalate, and mitigate regulatory risks to procedures and activities
Requisiti fondamentali
- University-level education, preferably in Life Sciences, or equivalent by experience
- Previous experience in regulatory affairs related to technical/CMC/quality in the pharmaceutical industry
- Strong understanding of CMC and post-approval regulatory requirements
- Experience in writing CMC (technical) sections of regulatory documents
- Knowledge of biological processes
- Background in validation/Quality Assurance/production with regulatory documentation experience
- Understanding of qualification/validation principles
- Proficiency in Word, PowerPoint, Excel; experience with Veeva Vault valued
- Team spirit, flexibility, accountability, and organizational skills
- Fluent in English (written and spoken)
Descrizione della posizione
In this Regulatory Affairs Consultant role, you will drive post-approval CMC regulatory activities for biological products across Europe, en…
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