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- Tasks: Lead regulatory strategy and submissions for complex product variations in Europe.
- Company: Join a growing business in Slough, focused on regulatory affairs.
- Benefits: Flexible working with 2 days on-site; gain valuable experience in a dynamic environment.
- Why this job: Make an impact in regulatory affairs while developing your expertise in a supportive team.
- Qualifications: Experience with EU regulatory procedures and strong understanding of CMC variations required.
- Other info: Immediate start available; contract runs until December 2025.
The predicted salary is between 36000 - 60000 £ per year.
Regulatory CMC Consultant – Six Month contract. INSIDE IR35
Blackfield Associates are actively supporting a client with an immediate requirement for an experience Regulatory professional to join an expanding business based in Slough.
As Regulatory CMC Consultant, you will:
Provide subject matter expertise on complex regulatory submissions involving legacy dossiers for solid, liquid and parenteral formulations. The ideal candidate will have significant experience in EU life cycle management and well versed in leading Safety and CMC variations for products approved via mutual recognition (MRP) and national procedures (NP) and will be capable of leading regulatory strategy and submission execution for established products.
Key Activities / Key Responsibilities:
- Lead regulatory strategy and submission preparation for Safety and some CMC variations for solid, liquid and parenteral formulations in Europe, UK and Switzerland
- Review and update outdated Safety and CMC documentation to align with current expectations
- Serve as Subject Matter Expert for Safety and CMC variations
- Strategically manage variations between regulatory planning and submission execution
Experience Required:
- Proven experience with EU regulatory procedures, especially MRP/DCP/NP
- Significant hands-on experience of preparing and submitting Safety and CMC variations and familiar with European regulatory requirements
- Ability to work independently and advise on best practices for legacy dossier life cycle management
- Strong understanding of regulatory strategy development and cross-functional coordination
- Available immediately and able to commit through to December 2025
Ideal candidates will be immediately available / short notice.
Must be able to work from site 2 days a week.
Unable to sponsor, all applicants must hold valid Right to Work status for the UK.
Regulatory Affairs Consultant employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Consultant
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with EU life cycle management. Attend industry events or webinars to connect with potential colleagues and learn about the latest trends and requirements in regulatory submissions.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks and guidelines for Safety and CMC variations in Europe, the UK, and Switzerland. This knowledge will not only boost your confidence but also demonstrate your commitment to understanding the role's requirements.
✨Tip Number 3
Prepare to discuss your previous experiences with legacy dossiers and how you've successfully managed regulatory submissions. Be ready to share specific examples that highlight your expertise in MRP, DCP, and NP procedures during the interview.
✨Tip Number 4
Showcase your ability to work independently by providing examples of past projects where you led regulatory strategy and submission execution. Highlight your problem-solving skills and how you effectively coordinated with cross-functional teams to achieve successful outcomes.
We think you need these skills to ace Regulatory Affairs Consultant
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience with EU regulatory procedures, particularly MRP/DCP/NP. Emphasise your hands-on experience with Safety and CMC variations, as well as your ability to manage legacy dossier life cycle.
Craft a Compelling Cover Letter: In your cover letter, explain why you are the ideal candidate for the Regulatory Affairs Consultant role. Mention specific examples of your past work that align with the key responsibilities outlined in the job description.
Highlight Relevant Skills: Clearly outline your skills related to regulatory strategy development and cross-functional coordination. This will demonstrate your capability to lead regulatory strategy and submission execution effectively.
Proofread Your Application: Before submitting, carefully proofread your application for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Blackfield Associates
✨Know Your Regulatory Framework
Familiarise yourself with the EU regulatory procedures, especially MRP, DCP, and NP. Be prepared to discuss your hands-on experience with Safety and CMC variations, as this will demonstrate your expertise in the field.
✨Showcase Your Strategic Thinking
Be ready to explain how you have developed regulatory strategies in the past. Highlight specific examples where you successfully managed variations between regulatory planning and submission execution.
✨Demonstrate Subject Matter Expertise
Prepare to discuss complex regulatory submissions and legacy dossiers. Illustrate your knowledge by providing examples of how you've served as a Subject Matter Expert in previous roles.
✨Highlight Your Independent Working Skills
Since the role requires the ability to work independently, share instances where you took initiative and advised on best practices for legacy dossier life cycle management. This will show your capability to thrive in a self-directed environment.
