Regulatory Affairs Consultant - CMC plasma products (home or office based)

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

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 and plasma products. For this role, we are looking for someone who has experience of conducting change control assessments for global markets (US, EU, CA, CH, AU, CN, and BR).

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, escape, 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 plasma products 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).