Regulatory Affairs Consultant (CMC for Vaccines) — Remote/EU

Parexel; England; À distance; GBP 60 000 - 100 000; Plein temps

Résumé du poste

Parexel is seeking an experienced Regulatory Affairs Consultant to join our dynamic team. This role can be office or home based in various European locations, offering flexibility for true remote work across Europe.

You will lead post-approval regulatory activities focused on CMC for vaccines or biologics, coordinating cross-functional efforts and driving submissions worldwide with a client-centric approach.

Qualifications

• University-level education in Life Sciences or equivalent by experience.
• Experience in regulatory affairs, especially technical/CMC/quality in pharma.
• Strong CMC and post-approval regulatory knowledge.
• Experience writing CMC sections for registrations or variations.
• Knowledge of vaccines or biological processes is required.
• Background in validation/QA/production with regulatory documentation.
• Proficiency with Word, PowerPoint, Excel; Veeva Vault is valued.
• Team-oriented, flexible, accountable, and organized.
• Fluent in English.

Responsabilités

• Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and 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, quality control and quality assurance, and other regulatory departments and local companies.
• Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
• Manage projects within Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
• Identify, escalation, and mitigate risks associated with regulatory procedures and activities.

Connaissances

Regulatory affairs

CMC knowledge

Regulatory documentation writing

Team spirit

Organizational skills

Formation

University-level Life Sciences degree

Outils

Word

PowerPoint

Excel

Veeva Vault

Description du poste

Parexel is seeking an experienced Regulatory Affairs Consultant to join our dynamic team. This role can be office or home based in various European locations, offering flexibility for true remote work across Europe.

You will lead post-approval regulatory activities focused on CMC for vaccines or biologics, coordinating cross-functional efforts and driving submissions worldwide with a client-centric approach.