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- Tasks: Join us as a Regulatory Affairs Consultant, focusing on CMC for biological products.
- Company: Lifelancer connects talent with exciting opportunities in Life Sciences and Pharma.
- Benefits: Enjoy flexible working options, whether from home or the office.
- Why this job: Make a real impact in global regulatory activities while collaborating with diverse teams.
- Qualifications: University degree in Life Sciences or equivalent experience in regulatory affairs required.
- Other info: This role is perfect for those passionate about compliance in the pharmaceutical industry.
The predicted salary is between 28800 - 48000 £ per year.
Regulatory Affairs Consultant – CMC biologics (home or office based), Uxbridge
Client:
Location:
Uxbridge, United Kingdom
Job Category:
Other
–
EU work permit required:
Yes
Job Reference:
efbf04be5a0f
Job Views:
14
Posted:
18.07.2025
Expiry Date:
01.09.2025
Job Description:
Job Title: Regulatory Affairs Consultant – CMC biologics (home or office based)
Job Location: Uxbridge, UK
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
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).
This job is curated by Lifelancer.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
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Regulatory Affairs Consultant - CMC biologics (home or office based) employer: Lifelancer
Contact Detail:
Lifelancer 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 with CMC biologics. Attend industry conferences or webinars to meet 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 help you in interviews but also demonstrate your commitment to the role and understanding of the industry.
✨Tip Number 3
Consider reaching out to current or former employees of StudySmarter or similar companies to gain insights into their experiences. This can provide you with valuable information about the company culture and expectations for the Regulatory Affairs Consultant role.
✨Tip Number 4
Prepare for potential interviews by practising answers to common questions related to CMC and regulatory affairs. Be ready to discuss specific examples from your past work that highlight your skills in managing regulatory submissions and compliance.
We think you need these skills to ace Regulatory Affairs Consultant - CMC biologics (home or office based)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly in CMC for biological products. Use keywords from the job description to demonstrate your fit for the role.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the responsibilities and requirements mentioned in the job description. Explain how your background in regulatory affairs aligns with their needs and express your enthusiasm for the position.
Showcase Relevant Experience: In your application, emphasise any previous roles where you developed submission strategies or managed regulatory documentation. Provide specific examples of your contributions to post-approval activities in the pharmaceutical industry.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Lifelancer
✨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 Project Management Skills
Since the role involves managing projects within Regulatory Information Management systems, highlight your project management experience. Discuss how you've coordinated with various departments in the past to ensure compliance and timely submissions.
✨Prepare for Technical Questions
Expect technical questions related to regulatory documentation and quality changes. Brush up on your knowledge of writing CMC sections and be ready to explain your approach to assessing change controls and ensuring compliance.
✨Demonstrate Team Spirit and Flexibility
This role requires collaboration across multiple teams. Share examples that showcase your ability to work well in a team environment, adapt to changing circumstances, and take accountability for your contributions.
