Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead regulatory submissions and provide strategic guidance for product development.
- Company: Join a well-established pharmaceutical company focused on innovation and generics.
- Benefits: Enjoy hybrid working, with flexibility to balance work and life.
- Why this job: Be part of a dynamic team making a real impact in the pharmaceutical industry.
- Qualifications: 5+ years in Regulatory Affairs with strong knowledge of EU submissions required.
- Other info: Must commute to Slough office 3 days a week.
The predicted salary is between 48000 - 72000 £ per year.
Blackfield Associates are supporting our client, a well-established generic and innovation pharmaceutical company based in Slough, in the search for a Regulatory Affairs Manager to join their expanding team. This is an exciting opportunity for a regulatory professional to play a pivotal role in the preparation, review, and strategic assessment of regulatory submissions across EU markets, particularly under the centralised procedure.
As Regulatory Affairs Manager, you will be responsible for:
- Review and Authoring of Modules 1–5 of regulatory dossiers in alignment with EMA and ICH requirements.
- Conduct independent due diligence assessments for in-licensing or acquisition of new product dossiers – including new chemical entities (NCEs) and generics.
- Perform detailed evaluations of Phase III clinical study data and CMC sections of dossiers, identifying regulatory risks and mitigation strategies.
- Provide strategic regulatory guidance to cross-functional teams during product development, submission planning, and lifecycle management.
- Maintain up-to-date knowledge of EU regulatory requirements and changes in legislation impacting product development and marketing authorisation.
To be considered for the role of Regulatory Affairs Manager, you will have the following:
- Proven experience in Regulatory Affairs within the pharmaceutical industry, with a strong focus on EU submissions, ideally minimum of 5 years.
- Strong working knowledge of CTD Modules 1–5, with demonstrable experience in authoring and reviewing content.
- Solid understanding of clinical trial data, particularly Phase III studies, and CMC documentation.
- Ability to independently perform regulatory due diligence for potential product acquisitions.
- Educated to Degree level in a scientific discipline.
This is a permanent role, hybrid working from the company's Slough based offices. Must be able to commute 3 days per week.
Regulatory Affairs Manager /Senior Manager employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager /Senior Manager
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those who work in regulatory affairs. Attend industry conferences or webinars to meet potential colleagues and learn about the latest trends and challenges in EU submissions.
✨Tip Number 2
Stay updated on the latest changes in EU regulatory requirements and guidelines. Subscribe to relevant newsletters or join online forums where regulatory affairs professionals discuss recent developments and share insights.
✨Tip Number 3
Consider reaching out to current or former employees of the company you're applying to. They can provide valuable insights into the company culture and expectations for the Regulatory Affairs Manager role.
✨Tip Number 4
Prepare to discuss specific examples from your experience that demonstrate your ability to handle regulatory submissions and due diligence assessments. Be ready to explain how you've navigated challenges in past roles and contributed to successful product launches.
We think you need these skills to ace Regulatory Affairs Manager /Senior Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Regulatory Affairs, particularly focusing on EU submissions and your familiarity with CTD Modules 1–5. Use specific examples from your past roles to demonstrate your skills.
Craft a Compelling Cover Letter: Write a cover letter that clearly outlines your relevant experience and why you are interested in the role. Mention your understanding of regulatory requirements and how you can contribute to the company's success.
Highlight Relevant Achievements: In your application, emphasise any significant achievements in your previous roles, such as successful submissions or strategic guidance provided during product development. This will help you stand out.
Proofread Your Application: Before submitting, carefully proofread your application 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 Blackfield Associates
✨Know Your Regulatory Framework
Make sure you have a solid understanding of the EU regulatory framework, especially regarding the centralised procedure. Brush up on the latest EMA and ICH guidelines, as this knowledge will be crucial during your interview.
✨Demonstrate Your Experience
Be prepared to discuss your previous experience in Regulatory Affairs, particularly your work with CTD Modules 1–5. Highlight specific examples where you've authored or reviewed regulatory dossiers, as this will showcase your expertise.
✨Showcase Your Strategic Thinking
During the interview, emphasise your ability to provide strategic regulatory guidance. Discuss how you've collaborated with cross-functional teams and contributed to product development and submission planning, as this is key for the role.
✨Stay Updated on Industry Changes
Demonstrate your commitment to staying informed about changes in EU regulations and legislation. Mention any recent updates you've followed and how they might impact product development and marketing authorisation.
