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- Tasks: Guide pharmaceutical products through compliance and regulatory submissions.
- Company: Join Smart4 Sciences, a dynamic pharmaceutical manufacturing company.
- Benefits: Enjoy a competitive salary and a supportive work environment.
- Why this job: Make a real impact on product lifecycle and regulatory strategy.
- Qualifications: Degree in Pharmacy or Life Sciences; experience in Regulatory Affairs required.
- Other info: Be part of a fast-moving team with a strong compliance culture.
The predicted salary is between 34000 - 51000 £ per year.
Pharmaceutical Regulatory Affairs Specialist | £40k – £45k | Hertfordshire | Permanent Are you a Regulatory Affairs professional with a sharp eye for compliance and a passion for guiding pharmaceutical products through every stage of their lifecycle? Smart4 Sciences are working with a pharmaceutical manufacturing company that\’s looking for an experienced Regulatory Affairs Specialist to join their team. This is an exciting opportunity to play a vital role in ensuring the company\’s products meet UK and EU regulatory standards from early development through post-marketing. Whether you\’re preparing submissions or staying ahead of evolving MHRA/EMA guidelines, this is a key position with real influence and variety. The Role: As Pharmaceutical Regulatory Affairs Specialist, you\’ll be responsible for: Preparing and submitting regulatory dossiers (MAAs, variations, renewals) to health authorities. Leading post-marketing activities, including Type IA, IB, II variations, sunset clauses, re-classifications, and gap analyses. Reviewing and approving product labelling and packaging for compliance. Monitoring and interpreting regulatory changes from the MHRA, EMA, and ICH, and ensuring company-wide alignment. Acting as the key liaison with regulatory authorities, managing communications, responses, and inspections. Supporting cross-functional teams including Quality, Manufacturing, and Development with regulatory input. Contributing to regulatory strategy and lifecycle planning for pharmaceutical products. What We\’re Looking For: Degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related discipline (advanced degree a bonus). Significant experience in Regulatory Affairs within the pharmaceutical industry. Solid understanding of EU/UK regulatory frameworks, including MHRA and EMA submissions. Strong knowledge of CMC (Chemistry, Manufacturing, and Controls) documentation and requirements. Familiarity with eCTD submissions and document management systems. A confident communicator who can represent the business to regulators and internal stakeholders alike. Ready for your next move? If you\’re a Regulatory Affairs specialist ready to join a fast-moving, supportive environment with a strong pipeline and clear compliance culture please apply today or contact Gareth Gooley at Smart4 Sciences on
Regulatory Affairs Specialist - Pharmaceuticals employer: Smart4Sciences
Contact Detail:
Smart4Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist - Pharmaceuticals
✨Tip Number 1
Network with professionals in the pharmaceutical regulatory field. Attend industry conferences or webinars where you can meet people who work at companies like Smart4 Sciences. Building these connections can give you insights into the company culture and potentially lead to referrals.
✨Tip Number 2
Stay updated on the latest regulatory changes from the MHRA and EMA. Subscribe to relevant newsletters or follow key organisations on social media. This knowledge will not only help you in interviews but also demonstrate your commitment to staying informed in this fast-evolving field.
✨Tip Number 3
Prepare to discuss specific examples of your experience with regulatory submissions and compliance. Think about challenges you've faced and how you overcame them, as well as any successful projects you've led. This will showcase your expertise and problem-solving skills during discussions.
✨Tip Number 4
Familiarise yourself with the company's products and their current regulatory status. Understanding their portfolio will allow you to speak more knowledgeably about how you can contribute to their regulatory strategy and lifecycle planning during your conversations.
We think you need these skills to ace Regulatory Affairs Specialist - Pharmaceuticals
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Regulatory Affairs Specialist. Familiarise yourself with the key tasks mentioned in the job description, such as preparing regulatory dossiers and monitoring changes from MHRA and EMA.
Tailor Your CV: Customise your CV to highlight relevant experience in Regulatory Affairs, particularly within the pharmaceutical industry. Emphasise your understanding of EU/UK regulatory frameworks and any specific achievements related to compliance and submissions.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your ability to guide products through their lifecycle. Mention specific experiences that demonstrate your skills in communication and collaboration with cross-functional teams.
Highlight Relevant Qualifications: Ensure you mention your degree in Pharmacy, Life Sciences, or Regulatory Affairs prominently. If you have an advanced degree or additional certifications, include those as well to strengthen your application.
How to prepare for a job interview at Smart4Sciences
✨Know Your Regulations
Familiarise yourself with the latest MHRA and EMA guidelines. Being able to discuss recent changes and how they impact the pharmaceutical industry will demonstrate your expertise and commitment to compliance.
✨Showcase Your Experience
Prepare specific examples from your past roles where you successfully managed regulatory submissions or navigated complex compliance issues. This will help illustrate your hands-on experience and problem-solving skills.
✨Communicate Clearly
As a Regulatory Affairs Specialist, you'll need to liaise with various stakeholders. Practice articulating your thoughts clearly and confidently, especially when discussing technical information or regulatory strategies.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's regulatory processes and challenges they face. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.
