Regulatory Affairs Consultant - Cmc

Parexel; England; À distance; GBP 60 000 - 100 000; Plein temps

Résumé du poste

Parexel is seeking an experienced Regulatory Affairs Consultant to join our dynamic team. This role can be office or home based in various European locations, offering flexibility for true remote work across Europe.

You will lead post-approval regulatory activities focused on CMC for vaccines or biologics, coordinating cross-functional efforts and driving submissions worldwide with a client-centric approach.

Qualifications

• University-level education in Life Sciences or equivalent by experience.
• Experience in regulatory affairs, especially technical/CMC/quality in pharma.
• Strong CMC and post-approval regulatory knowledge.
• Experience writing CMC sections for registrations or variations.
• Knowledge of vaccines or biological processes is required.
• Background in validation/QA/production with regulatory documentation.
• Proficiency with Word, PowerPoint, Excel; Veeva Vault is valued.
• Team-oriented, flexible, accountable, and organized.
• Fluent in English.

Responsabilités

• 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 QC and production to ensure regulatory compliance.
• Coordinate submission preparation with 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 Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
• Identify, escalation, and mitigate risks associated with regulatory procedures and activities.

Connaissances

Regulatory affairs

CMC knowledge

Regulatory documentation writing

Team spirit

Organizational skills

Formation

University-level Life Sciences degree

Outils

Word

PowerPoint

Excel

Veeva Vault

Description du poste

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

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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 vaccines or 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, escalation, 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 vaccines or biological 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 .

Company Overview

Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere.

Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.