Remote Regulatory Affairs Consultant - CMC Post-Approval EU

Parexel International; United States; On-site; GBP 60,000 - 90,000; Full time

Job summary

Parexel International is seeking a Regulatory Affairs Consultant to lead post-approval CMC activities across global markets. You will develop submission strategies for variations, renewals, and annual reports, review regulatory content, and coordinate submissions with manufacturing, QA, and supply chain teams.

Fluent English and solid CMC expertise are essential. Experience with plasma products, validation/QA, and Veeva Vault is valued; you’ll work on a client-dedicated project with hybrid

Qualifications

• University-level education, preferably in Life Sciences, or equivalent by experience.
• 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 plasma products processes.
• 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; experience with Veeva Vault is valued.
• Team spirit, flexibility, accountability, and organizational skills.
• Fluent in English (written and spoken).

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, escalation, and mitigate risks associated with regulatory procedures and activities.

Skills

Regulatory affairs experience

CMC knowledge

Post-approval regulatory requirements

Writing CMC sections

Plasma products processes knowledge

Validation/QA/production background

Teamwork and organizational skills

Fluent English

Education

Life sciences degree

Tools

Veeva Vault

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Job description

Parexel International is seeking a Regulatory Affairs Consultant to lead post-approval CMC activities across global markets. You will develop submission strategies for variations, renewals, and annual reports, review regulatory content, and coordinate submissions with manufacturing, QA, and supply chain teams.

Fluent English and solid CMC expertise are essential. Experience with plasma products, validation/QA, and Veeva Vault is valued; you’ll work on a client-dedicated project with hybrid