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- Tasks: Lead regulatory strategy and manage submissions for product variations in Europe.
- Company: Join a growing business in Slough focused on regulatory affairs.
- Benefits: Work on-site 2 days a week with flexible hours and a collaborative environment.
- Why this job: Be a key player in shaping regulatory strategies and making an impact in the industry.
- Qualifications: Experience with EU regulatory procedures and strong knowledge of Safety and CMC variations required.
- Other info: Immediate start available; must have valid Right to Work status in the UK.
The predicted salary is between 43200 - 72000 £ per year.
Blackfield Associates are actively supporting a client with an immediate requirement for an experienced Regulatory professional to join an expanding business based in Slough.
As Regulatory Affairs Manager, 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 be well versed in leading Safety and some CMC variations for products approved via mutual recognition (MRP) and national procedures (NP). You 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- Review and update outdated Safety and CMC documentation to align with current expectations.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.
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨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 challenges in regulatory submissions.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks and guidelines relevant to solid, liquid, and parenteral formulations. This knowledge will not only boost your confidence but also demonstrate your commitment to understanding the complexities of the role.
✨Tip Number 3
Prepare to discuss your previous experiences with Safety and CMC variations during interviews. Be ready to provide examples of how you've successfully managed regulatory strategies and submissions, as this will showcase your expertise and problem-solving skills.
✨Tip Number 4
Stay updated on the latest changes in EU regulatory procedures, particularly regarding MRP and DCP. Being knowledgeable about recent developments will help you stand out as a candidate who is proactive and well-informed about the industry.
We think you need these skills to ace Regulatory Affairs Manager
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 any relevant achievements in regulatory strategy development.
Craft a Compelling Cover Letter: In your cover letter, address the specific requirements mentioned in the job description. Discuss your expertise in lifecycle management and how you can contribute to the company's regulatory strategy. Be sure to mention your ability to work independently and your understanding of best practices.
Showcase Relevant Experience: When detailing your previous roles, focus on your experience with legacy dossiers and your ability to manage variations between regulatory planning and submission execution. Use specific examples to demonstrate your knowledge and skills in this area.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. Ensure that your information is clear and concise, as attention to detail is crucial in regulatory affairs.
How to prepare for a job interview at Blackfield Associates
✨Know Your Regulatory Framework
Make sure you have a solid understanding of EU regulatory procedures, especially MRP, DCP, and NP. Brush up on the latest guidelines and be prepared to discuss how your experience aligns with these frameworks.
✨Demonstrate Your Expertise
Be ready to showcase your subject matter expertise in Safety and CMC variations. Prepare examples from your past work where you successfully led regulatory strategy and submission execution for established products.
✨Highlight Your Independent Working Skills
Since the role requires the ability to work independently, think of instances where you took initiative or led projects without much oversight. This will show your potential employer that you can manage responsibilities effectively.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about challenges you've faced in lifecycle management and how you navigated them, particularly regarding legacy dossiers.
