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- Tasks: Manage regulatory submissions and ensure compliance for a diverse range of generic medicines.
- Company: Established generics pharmaceutical company with a strong UK and EU presence.
- Benefits: Hybrid working, career development, and ongoing training opportunities.
- Other info: Fast-paced environment with exposure to a broad generics portfolio.
- Why this job: Join a collaborative team and make a real impact in the pharmaceutical industry.
- Qualifications: Degree in Life Sciences or Pharmacy and proven Regulatory Affairs experience.
The predicted salary is between 45000 - 55000 £ per year.
Your new company is an established, research-driven generics pharmaceutical company with a strong presence across the UK and EU markets. The organisation offers a collaborative, team-oriented environment and is committed to delivering high-quality, affordable medicines while supporting employee development.
Your new role involves supporting the lifecycle management of a diverse portfolio of generic medicinal products. You will be responsible for preparing and submitting regulatory dossiers (including MAAs, variations, and renewals) in line with MHRA and EMA requirements, as well as managing post-approval activities. You will liaise with regulatory authorities, respond to queries within agreed timelines, and ensure compliance of product labelling and documentation (SmPCs, PILs, artwork). The role also involves supporting regulatory strategy, tracking submission timelines, and monitoring evolving regulatory guidelines to assess business impact.
What you'll need to succeed:
- Degree in Life Sciences, Pharmacy, or a related field
- Proven Regulatory Affairs experience within the pharmaceutical industry (generics preferred)
- Strong knowledge of UK (MHRA) and EU regulatory frameworks
- Experience with CTD/eCTD submissions and lifecycle management
- Familiarity with variations and post-approval processes
- Excellent organisational and communication skills
- Ability to manage multiple projects in a fast-paced environment
- Full UK right to work
What you'll get in return:
- Hybrid working (3 days onsite in London, 2 days remote)
- Opportunity to work within a collaborative and supportive team
- Exposure to a broad and varied generics portfolio across UK and EU markets
- Career development and ongoing training opportunities
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
Senior Regulatory Affairs Associate in London employer: Hays Life Sciences
Contact Detail:
Hays Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Associate in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those in regulatory affairs. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK and EU regulatory frameworks. We recommend creating a list of common interview questions and practising your responses to showcase your expertise.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a thank-you email to express your appreciation and reiterate your interest in the role. It keeps you fresh in their minds.
✨Tip Number 4
Apply through our website for the best chance at landing that Senior Regulatory Affairs Associate role. We’re all about making the process smooth and ensuring your application gets the attention it deserves!
We think you need these skills to ace Senior Regulatory Affairs Associate in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in Regulatory Affairs, especially with generics. We want to see how your skills align with the role, so don’t be shy about showcasing your knowledge of MHRA and EMA requirements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how you can contribute to our mission of delivering high-quality medicines. Keep it concise but impactful!
Showcase Your Organisational Skills: Since the role involves managing multiple projects, highlight any experiences where you’ve successfully juggled tasks or met tight deadlines. We love seeing candidates who can keep things on track in a fast-paced environment!
Apply Through Our Website: We encourage you to apply directly through our website for a smoother process. It helps us keep everything organised and ensures your application gets the attention it deserves. Plus, it’s super easy!
How to prepare for a job interview at Hays Life Sciences
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of UK (MHRA) and EU regulatory frameworks. Be ready to discuss specific examples from your experience with CTD/eCTD submissions and lifecycle management, as this will show that you’re not just familiar with the theory but have practical insights too.
✨Showcase Your Organisational Skills
Since the role involves managing multiple projects in a fast-paced environment, prepare to share how you've successfully juggled various tasks in the past. Use concrete examples to illustrate your organisational skills and ability to meet tight deadlines.
✨Communicate Clearly
Excellent communication is key in this role, especially when liaising with regulatory authorities. Practice articulating your thoughts clearly and concisely, and be prepared to answer questions about how you handle queries and ensure compliance with product labelling and documentation.
✨Stay Updated on Regulatory Changes
Demonstrate your proactive approach by discussing how you keep track of evolving regulatory guidelines. Mention any resources or networks you use to stay informed, as this shows your commitment to continuous learning and adapting to changes in the industry.