Overview

In this role you will support worldwide post-approval regulatory activities focused on CMC for vaccines or biological products. You will work within a regulatory team to shape submission strategies, assess quality-related changes, and coordinate cross-functional input for regulatory dossiers. The position emphasizes collaboration across manufacturing, QA, QC, and regulatory groups to ensure compliant submissions. You will help manage regulatory information systems and identify risks to timelines and approvals. You will contribute to Parexel’s mission of improving global health by enabling efficient regulatory pathways for life-saving therapies.

Responsabilità

- Develop post-approval CMC submission strategies for variations, renewals, expansions, and annual reports
- Assess change controls and regulatory implications of production and quality changes
- Review study reports for regulatory compliance across QC and production
- Coordinate submission preparation with manufacturing, supply chain, QA, and other regulatory teams

- Prepare and review submission content aligned with regulatory requirements for variations and health authority questions
- Manage projects within Regulatory Information Management systems for worldwide submissions
- Identify, escalate, and mitigate regulatory risks and issues

Requisiti fondamentali

- University-level education in Life Sciences or equivalent
- Experience in regulatory affairs, especially technical/CMC/quality in pharma
- Strong knowledge of CMC and post-approval regulatory requirements
- Experience writing CMC sections of regulatory documents (registration files or variations)
- Knowledge of vaccines or biological processes
- Background in validation/QA/production with regulatory documentation experience
- Understanding of qualification/validation principles
- Proficiency in 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
- post-approval regulatory requirements
- regulatory writing (CMC sections)

Regulatory Affairs Consultant - CMC vax/bio (home or office based)

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