Senior Regulatory Affairs Associate – CMC for Vaccines

Parexel; United States; A distancia; USD 110.000 - 160.000; Jornada completa

Descripción de la vacante

Parexel is seeking a Senior Regulatory Affairs Associate to join our global team. This role focuses on post-approval CMC activities for biological and vaccine products, with work supporting variations, renewals, and global submissions.

The position may be office- or home-based and offers opportunities across European locations. The Senior RA Associate will contribute to regulatory strategy, document preparation, and cross-functional collaboration to ensure compliance with health authorities.

Formación

• Experience in regulatory affairs, especially technical/CMC/quality in pharma.
• Strong understanding of CMC and post-approval requirements.
• Experience writing CMC sections for registration files or variations.
• Knowledge of biological or vaccine processes.
• Experience with qualification/validation principles.
• Proficiency with MS Office and familiarity with Veeva Vault.

Responsabilidades

• 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 to ensure compliance with regulatory requirements.
• Coordinate submission preparation with manufacturing, supply chain, QA/QC, and other regulatory departments and local companies.
• Write and/or review submission content to align with regulatory requirements for variations and health authority questions.
• Manage projects within Regulatory Information Management systems and worldwide submissions.
• Identify, escal...

Conocimientos

Regulatory excellence

English fluency

Teamwork & collaboration

Organizational skills

Educación

University-level education in Life Sciences or equivalent by experience

Herramientas

Veeva Vault

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Descripción del empleo

Parexel is seeking a Senior Regulatory Affairs Associate to join our global team. This role focuses on post-approval CMC activities for biological and vaccine products, with work supporting variations, renewals, and global submissions.

The position may be office- or home-based and offers opportunities across European locations. The Senior RA Associate will contribute to regulatory strategy, document preparation, and cross-functional collaboration to ensure compliance with health authorities.