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

Parexel; España; On-site; EUR 60,000 - 90,000; Full time

Job summary

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.

Qualifications

• 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).

Responsibilities

• 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.

Skills

Regulatory affairs

CMC knowledge

Post-approval submissions

GxP/QA experience

Veeva Vault

English fluency

Documentation writing

Project coordination

Biologics/vaccines knowledge

Regulatory strategy

Education

University degree in Life Sciences

Tools

Veeva Vault

Job description

Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented Regulatory Affairs Consultant to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations.

As the Regulatory Affairs Consultant you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for vaccines or biological products.

Primary Tasks & Responsibilities

• 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 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, escalat,e and mitigate risks associated with regulatory procedures and activities.

Experience And Knowledge Requirements

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