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- Tasks: Lead regulatory submissions and provide strategic guidance in a dynamic pharmaceutical environment.
- Company: Join a well-established pharmaceutical company known for innovation and growth.
- Benefits: Enjoy hybrid working, flexible hours, and opportunities for professional development.
- Why this job: Make a real impact on product development while working with cross-functional teams.
- Qualifications: 5+ years in Regulatory Affairs with a degree in a scientific discipline 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 companies Slough based offices. Must be able to commute 3 days per week.
Compliance Manager/Senior Manager employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Compliance 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. Follow relevant regulatory bodies and subscribe to newsletters that provide insights into new legislation affecting product development and marketing authorisation.
✨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, which can help you tailor your approach.
✨Tip Number 4
Prepare to discuss specific examples from your experience that demonstrate your ability to handle regulatory submissions and due diligence assessments. Highlight your familiarity with CTD Modules 1–5 and any successful projects you've led in the past.
We think you need these skills to ace Compliance Manager/Senior Manager
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Compliance Manager position. Familiarise yourself with the key tasks such as regulatory submissions, due diligence assessments, and strategic guidance.
Tailor Your CV: Customise your CV to highlight relevant experience in Regulatory Affairs, particularly focusing on EU submissions and your knowledge of CTD Modules 1–5. Use specific examples from your past roles that demonstrate your expertise in these areas.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the pharmaceutical industry and your understanding of regulatory processes. Mention your experience with Phase III clinical studies and how you can contribute to the company's goals.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for any spelling or grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial for a Compliance Manager.
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 CTD Modules 1–5. Be prepared to discuss how your experience aligns with EMA and ICH requirements, as this will demonstrate your expertise in the field.
✨Showcase Your Due Diligence Skills
Be ready to provide examples of how you've conducted independent due diligence assessments in the past. Highlight any specific cases involving new chemical entities or generics, as this will show your capability in evaluating regulatory risks.
✨Discuss Strategic Guidance Experience
Prepare to talk about instances where you've provided strategic regulatory guidance to cross-functional teams. This could include product development or submission planning, so think of specific examples that illustrate your collaborative approach.
✨Stay Updated on Regulatory Changes
Demonstrate your commitment to staying informed about changes in EU regulatory requirements. Mention any recent updates you've followed and how they might impact product development and marketing authorisation, showcasing your proactive attitude.
