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For Companies At a Glance
- 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 in Slough.
- Benefits: Enjoy hybrid working, competitive salary, and opportunities for professional development.
- Why this job: Make a real impact on product development while collaborating with diverse teams.
- Qualifications: 5+ years in Regulatory Affairs with strong EU submission experience and a scientific degree.
- Other info: Must commute to the Slough office 3 days a week; no sponsorship available.
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.
- Lead the preparation and submission of marketing authorisation applications via the Centralised Procedure.
- 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.
- Liaise with external partners, consultants, and Health Authorities as needed to support dossier development and submission activities.
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.
- Direct experience with EMA and Centralised Procedures is essential - Experience with DCP and MRP pathways is advantageous.
- 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.
- Highly detail-oriented, with strong analytical and communication skills.
- 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. Unable to sponsor, all applicants must hold valid Right to Work status for the UK.
Regulatory Affairs Manager employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Familiarise yourself with the latest EU regulatory guidelines and changes. Staying updated on EMA requirements will not only enhance your knowledge but also demonstrate your commitment to the role during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with centralised procedures. Engaging in discussions or attending relevant webinars can provide insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences with regulatory submissions, particularly those involving Modules 1-5. Being able to articulate your contributions and outcomes will set you apart from other candidates.
✨Tip Number 4
Consider reaching out to current or former employees of the company for informational interviews. This can give you a better understanding of the company culture and expectations, which you can leverage in your application process.
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 relevant experience in Regulatory Affairs, particularly focusing on EU submissions and your familiarity with EMA and Centralised Procedures. Use specific examples to demonstrate your expertise in authoring and reviewing CTD Modules.
Craft a Compelling Cover Letter: Write a cover letter that clearly outlines 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.
Highlight Relevant Skills: In your application, emphasise your analytical skills, attention to detail, and ability to provide strategic guidance. These are crucial for the role and should be evident in your written materials.
Proofread Your Application: Before submitting, thoroughly proofread your CV and cover letter to eliminate any errors. A polished application reflects your professionalism and attention to detail, which is vital 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 EMA and ICH requirements. Brush up on the Centralised Procedure and be ready to discuss how your experience aligns with these regulations.
✨Showcase Your Dossier Experience
Prepare to talk about your experience with CTD Modules 1–5. Be specific about your role in authoring and reviewing these documents, and highlight any successful submissions you've led.
✨Demonstrate Analytical Skills
Be ready to discuss how you've evaluated Phase III clinical study data and CMC documentation in the past. Provide examples of how you've identified regulatory risks and proposed mitigation strategies.
✨Communicate Effectively
Strong communication skills are key in this role. Practice articulating complex regulatory concepts clearly and concisely, especially when discussing your strategic guidance to cross-functional teams.
