Regulatory Affairs Consultant - CMC biologics (home or office based)

Parexel; London; Hybrid; GBP 40,000 - 65,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Regulatory Affairs Consultant focused on CMC biologics, with the option for home or office-based work in London. The role demands expertise in post-approval regulatory activities and collaboration across various departments to ensure compliance and manage submissions efficiently.

Qualifications

• Previous experience in regulatory affairs, particularly in the pharmaceutical industry.
• Strong understanding of CMC and post-approval regulatory requirements.
• Experience in writing CMC technical sections of regulatory documents.

Responsibilities

• Develop submission strategies for post-approval CMC activities.
• Assess change controls and provide regulatory assessments.
• Coordinate submission preparation with various departments.

Skills

Regulatory affairs

CMC knowledge

Quality Assurance

Project management

Strong organizational skills

Team spirit

Education

University-level education in Life Sciences

Tools

Veeva Vault

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Job description

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Regulatory Affairs Consultant - CMC biologics (home or office based), London

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Client:

Parexel

Location:

London, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

3f1ffad660cb

Job Views:

4

Posted:

22.06.2025

Expiry Date:

06.08.2025

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Job Description:

When our values align, there's no limit to what we can achieve.

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 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, escalate, 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 biological 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, and experience with Veeva Vault is valued.

Team spirit, flexibility, accountability, and organizational skills.