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

TN United Kingdom; London; Hybrid; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a skilled Regulatory Affairs Consultant to join their dynamic team in London. This role offers the flexibility of home or office-based work and focuses on critical post-approval regulatory activities related to Chemistry, Manufacturing, and Controls (CMC) for biological products. The successful candidate will develop submission strategies, manage regulatory assessments, and coordinate with various departments to ensure compliance. If you have a background in regulatory affairs and a passion for ensuring product quality, this opportunity could be your next career move.

Qualifications

• Experience in regulatory affairs, specifically in CMC and quality.
• Strong understanding of post-approval regulatory requirements.

Responsibilities

• Develop submission strategies for post-approval CMC activities.
• Review study reports to ensure compliance with regulatory requirements.

Skills

Regulatory Affairs

CMC Knowledge

Quality Control

Project Management

Communication Skills

Education

University-level education in Life Sciences

Tools

Word

PowerPoint

Excel

Veeva Vault

Job description

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

Client: Parexel

Location: London, United Kingdom

Job Category: Consulting

EU work permit required: Yes

Job Reference: 3f1ffad660cb

Job Views: 1

Posted: 07.05.2025

Expiry Date: 21.06.2025

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.