Remote Regulatory Affairs Consultant - CMC & Post-Approval

Parexel; Uxbridge; Hybrid; GBP 65,000 - 90,000; Full time

Job summary

Parexel is looking for an experienced Regulatory Affairs Consultant to join our team on a client dedicated project. The role can be office or home based in various European locations, with a focus on post-approval CMC activities for biological and plasma products.

You will develop submission strategies, assess change controls, coordinate submissions, and manage regulatory information systems to ensure timely global submissions and regulatory compliance.

Qualifications

• Life sciences degree or equivalent by experience.
• Experience in regulatory affairs focusing on technical/CMC/quality in pharma.
• Experience writing CMC sections for regulatory documents.
• Knowledge of plasma products processes is required.
• Validation/QA/production background with regulatory documentation experience.

Responsibilities

• Develop submission strategies and plans for post-approval CMC activities like variations, renewals, market expansions, and annual reports.
• Assess change controls and provide regulatory assessments of quality changes.
• Review study reports to ensure regulatory compliance.
• Coordinate submission preparation with manufacturing, supply chain, QA/QC, and other regulatory departments and local companies.
• Write/review submission content for variations and health authority inquiries.
• Manage projects within Regulatory Information Management systems for worldwide submissions.
• Identify and mitigate risks in regulatory procedures.

Skills

CMC knowledge

Regulatory submissions

Veeva Vault

Regulatory writing

English fluency

Education

University degree Life Sciences

Tools

MS Office

Word

Excel

PowerPoint

Job description

Parexel is looking for an experienced Regulatory Affairs Consultant to join our team on a client dedicated project. The role can be office or home based in various European locations, with a focus on post-approval CMC activities for biological and plasma products.

You will develop submission strategies, assess change controls, coordinate submissions, and manage regulatory information systems to ensure timely global submissions and regulatory compliance.