At a Glance
- Tasks: Join our team to manage regulatory activities for plasma products and ensure compliance.
- Company: Dynamic company focused on innovative regulatory solutions in the pharmaceutical industry.
- Benefits: Flexible work options, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on career development and teamwork.
- Why this job: Make a real impact in global markets while working with cutting-edge plasma technologies.
- Qualifications: Experience in regulatory affairs and strong understanding of CMC requirements.
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).
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Regulatory Affairs Consultant - CMC plasma products (home or office based) in Uxbridge employer: PAREXEL
At Parexel, we pride ourselves on being an exceptional employer, offering a collaborative work culture that fosters innovation and professional growth. Our team members enjoy competitive benefits, including flexible working arrangements and opportunities for career advancement, all while contributing to impactful global clinical trials in a supportive environment across the UK, Poland, Serbia, and Hungary.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Consultant - CMC plasma products (home or office based) in Uxbridge
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Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at PAREXEL!
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How to prepare for a job interview at PAREXEL
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at PAREXEL that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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