At a Glance
- Tasks: Develop regulatory strategies for post-approval activities in vaccines and biological products.
- Company: Join Parexel, a leader in improving global health through innovative solutions.
- Benefits: Flexible work options, competitive salary, and opportunities for professional growth.
- Other info: Dynamic team environment with a commitment to empathy and making an impact.
- Why this job: Make a real difference in healthcare by ensuring compliance and quality in life-saving therapies.
- Qualifications: Experience in regulatory affairs, particularly in CMC, and a background in Life Sciences.
The predicted salary is between 50000 - 70000 € per year.
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, escalate, and mitigate risks associated with regulatory procedures and activities.
- 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 English (written and spoken).
Regulatory Affairs Consultant - CMC vax/bio (home or office based) employer: Parexel
At Parexel, we pride ourselves on fostering a collaborative and inclusive work environment where every employee is empowered to make a meaningful impact on global health. With flexible working options available, whether from home or in the office, we offer our Regulatory Affairs Consultants not only competitive benefits but also ample opportunities for professional growth and development within the dynamic field of regulatory affairs. Join us in our mission to improve patient outcomes and be part of a team that values empathy, innovation, and dedication.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Consultant - CMC vax/bio (home or office based)
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, especially those who work at Parexel or similar companies. A friendly chat can open doors and give you insider info on job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your CMC knowledge and recent regulatory changes. We recommend practising common interview questions and having examples ready that showcase your experience in managing post-approval activities.
✨Tip Number 3
Don’t just apply; engage! When you submit your application through our website, follow up with a quick email to express your enthusiasm for the role. It shows initiative and keeps you on the radar.
✨Tip Number 4
Stay updated on industry trends and regulations. Join relevant forums or groups where professionals discuss the latest in regulatory affairs. This not only boosts your knowledge but also helps you connect with potential employers.
We think you need these skills to ace Regulatory Affairs Consultant - CMC vax/bio (home or office based)
Some tips for your application 🫡
Show Your Passion:When writing your application, let your enthusiasm for regulatory affairs shine through. We want to see that you genuinely care about improving health and have a strong commitment to making a difference in the industry.
Tailor Your CV:Make sure your CV is tailored to highlight your experience in CMC and regulatory affairs. We’re looking for specific examples of your work with vaccines or biological products, so don’t hold back on those details!
Be Clear and Concise:Keep your application clear and to the point. Use straightforward language and avoid jargon where possible. We appreciate a well-structured application that makes it easy for us to see your qualifications at a glance.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re serious about joining our team!
How to prepare for a job interview at Parexel
✨Know Your CMC Inside Out
Make sure you brush up on your Chemistry, Manufacturing, and Controls (CMC) knowledge. Be ready to discuss specific regulatory requirements and how they apply to vaccines or biological products. This will show that you’re not just familiar with the basics but have a deep understanding of the field.
✨Showcase Your Project Management Skills
Since the role involves managing projects within Regulatory Information Management systems, be prepared to share examples of how you've successfully managed similar projects in the past. Highlight your organisational skills and how you’ve coordinated with different departments to achieve compliance.
✨Prepare for Scenario-Based Questions
Expect questions that put you in hypothetical situations related to regulatory assessments or change controls. Think about how you would identify, escalate, and mitigate risks in these scenarios. Practising these responses can help you feel more confident during the interview.
✨Emphasise Team Spirit and Flexibility
Parexel values teamwork and adaptability, so be ready to discuss how you’ve worked collaboratively in previous roles. Share specific instances where your flexibility made a difference in achieving project goals, especially in a regulatory context.
