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- Tasks: Join us as a Regulatory Affairs Consultant, focusing on CMC for biological products.
- Company: Parexel is a leading global biopharmaceutical services company dedicated to helping clients accelerate the development of innovative therapies.
- Benefits: Enjoy flexible working options, competitive salary, and opportunities for professional growth.
- Why this job: Be part of a dynamic team making a real impact in the pharmaceutical industry.
- Qualifications: University-level education in Life Sciences or equivalent experience; regulatory affairs background required.
- Other info: This role can be performed from home or office across various European locations.
The predicted salary is between 36000 - 60000 £ per year.
Regulatory Affairs Consultant – CMC biologics (home or office based)
Parexel Uxbridge, England, United Kingdom
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Regulatory Affairs Consultant – CMC biologics (home or office based)
Parexel Uxbridge, England, United Kingdom
Join to apply for the Regulatory Affairs Consultant – CMC biologics (home or office based) role at Parexel
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 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.
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 biological processes.
- 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).
Seniority level
-
Seniority level
Mid-Senior level
Employment type
-
Employment type
Full-time
Job function
-
Job function
Research and Consulting
-
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care
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Regulatory Affairs Consultant - CMC biologics (home or office based) employer: Parexel
Contact Detail:
Parexel Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Consultant - CMC biologics (home or office based)
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience in CMC biologics. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and requirements in the sector.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks and guidelines related to CMC for biological products. This knowledge will not only boost your confidence during interviews but also demonstrate your commitment to the role.
✨Tip Number 3
Prepare to discuss your previous experiences in regulatory affairs, particularly any projects involving CMC submissions. Be ready to share specific examples of how you managed challenges and contributed to successful outcomes.
✨Tip Number 4
Showcase your proficiency in relevant software tools like Veeva Vault during discussions. Highlighting your technical skills can set you apart from other candidates and demonstrate your readiness for the role.
We think you need these skills to ace Regulatory Affairs Consultant - CMC biologics (home or office based)
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Regulatory Affairs Consultant focused on CMC biologics. Familiarise yourself with the specific tasks mentioned in the job description, such as developing submission strategies and reviewing study reports.
Tailor Your CV: Highlight your relevant experience in regulatory affairs, particularly in CMC and quality within the pharmaceutical industry. Make sure to include any specific projects or achievements that demonstrate your expertise in writing technical sections of regulatory documents.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your enthusiasm for the role. Mention how your background aligns with the requirements, such as your understanding of post-approval regulatory requirements and your proficiency in relevant software.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. Ensure that your application is clear, concise, and free of mistakes, as attention to detail is crucial in regulatory affairs.
How to prepare for a job interview at Parexel
✨Know Your CMC Inside Out
Make sure you have a solid understanding of Chemistry, Manufacturing, and Controls (CMC) as it relates to biological products. Be prepared to discuss specific examples from your past experience where you successfully navigated post-approval regulatory activities.
✨Showcase Your Regulatory Writing Skills
Since the role involves writing and reviewing submission content, be ready to highlight your experience in crafting CMC sections of regulatory documents. Bring samples or be prepared to discuss how you ensure compliance with regulatory requirements.
✨Demonstrate Team Collaboration
This position requires coordination with various departments. Share examples of how you've effectively collaborated with teams such as manufacturing, quality control, and regulatory affairs to achieve project goals.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills, especially regarding risk management in regulatory procedures. Think of scenarios where you identified and mitigated risks in previous roles, and be ready to discuss your thought process.
