Regulatory Affairs Consultant, CMC (Vax/Bio) - Remote

Parexel; España; Presencial; EUR 60 000 - 90 000; Tempo integral

Resumo da oferta

Parexel is seeking an experienced Regulatory Affairs Consultant to join our team on a client-dedicated project. The role can be office or home based across European locations, focusing on post-approval CMC activities for vaccines or biologics.

You will develop submission strategies, assess change controls, coordinate with manufacturing and QA, and manage regulatory submissions in global systems. Fluent English and a strong pharma background are required.

Qualificações

• University-level education in Life Sciences or equivalent by experience.
• Experience in regulatory affairs related to technical/CMC/quality in pharma.
• Strong understanding of CMC and post-approval requirements.
• Experience writing CMC sections of regulatory documents (registration files or variations).
• Knowledge of vaccines or biological processes.
• Background in validation/Quality Assurance/production with regulatory documentation experience.
• Proficiency with Word, PowerPoint, Excel; experience with Veeva Vault is valued.
• Team spirit, flexibility, accountability, and organizational skills.
• Fluent in English (written and spoken).

Responsabilidades

• Develop submission strategies 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 the quality control and production departments to ensure compliance with regulatory requirements.
• Coordinate submission preparation with various departments including 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 all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
• Identify, escalate, and mitigate risks associated with regulatory procedures and activities.

Conhecimentos

Regulatory affairs

CMC knowledge

Post-approval submissions

GxP/QA experience

Veeva Vault

English fluency

Documentation writing

Project coordination

Biologics/vaccines knowledge

Regulatory strategy

Formação académica

University degree in Life Sciences

Ferramentas

Veeva Vault

Descrição da oferta de emprego

Parexel is seeking an experienced Regulatory Affairs Consultant to join our team on a client-dedicated project. The role can be office or home based across European locations, focusing on post-approval CMC activities for vaccines or biologics.

You will develop submission strategies, assess change controls, coordinate with manufacturing and QA, and manage regulatory submissions in global systems. Fluent English and a strong pharma background are required.