At a Glance
- Tasks: Ensure global compliance with regulatory requirements throughout the product lifecycle.
- Company: Join Productlife Group, a growing life sciences company with a hybrid working model.
- Benefits: Flexible working options, competitive salary, and opportunities for professional growth.
- Other info: Supportive team environment with opportunities to mentor junior members.
- Why this job: Make a real impact in the life sciences sector while developing your regulatory expertise.
- Qualifications: Bachelor’s degree in Life Sciences or Pharmacy and 5+ years in Regulatory Affairs.
The predicted salary is between 50000 - 60000 € per year.
About the role
Productlife Group is seeking a motivated and detail-oriented Regulatory Affairs Specialist to join our growing life sciences company. In this role, you will ensure global compliance with regulatory requirements throughout the product lifecycle, from development and approval to post‑market maintenance. The position can be based at our offices in Lockington with a hybrid working model or remotely within the UK with bimonthly travel to our offices.
Key Responsibilities
- Contribute to the production of client administrative documents and reports for regulatory submissions
- Compile or supervise the compilation of regulatory dossiers in accordance with national requirements
- Complete and advise on regulatory activities including regulatory strategy
- Independently prepare regulatory submissions for medicinal products (new license applications, variations, responses to questions, renewals)
- Coordinate and review technical documentation
- Prepare and review user testing readability reports
- Involve with medical device regulatory work
- Write sections of Module 3 of dossiers and Quality Overall Summaries
- Advise on technical activities relating to all product types
- Provide technical support within the regulatory framework
- Provide general technical advice based on industry experience
- Prepare clinical and non‑clinical overviews and summaries
- Support junior team members in their development and training
- Document and track regulatory submissions and obtain regulatory authority approval
- Assess regulation and inform clients about impact on their products or activities; liaise with external regulatory authorities as required
- Provide format and content review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling
- Provide ongoing regulatory support to the Regulatory Affairs Team Lead and project teams to ensure regulatory concerns are planned, accounted for, and relevant data are generated to meet objectives
- Manage systems and administer administrative tasks
- Review tasks, support and mentor Regulatory Affairs Associates team members
- Provide regulatory support to clients and associate companies
Experience and Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field (Master’s degree or higher is a plus)
- 5+ years of relevant experience in Regulatory Affairs, focusing on UK market and regulations
- In-depth knowledge of UK and EU regulatory authorities and frameworks
- Proven experience analysing and writing regulatory documents and acting as liaison with competent authorities
- Medical writing experience highly advantageous
- Strong knowledge of the lifecycle maintenance of medical products
- Experience providing regulatory support to clients and being the main point of contact
- Strong attention to detail and organisational skills with ability to prioritise tasks and deliver high-quality work in a fast‑paced environment
- Excellent communication skills, both written and verbal
Regulatory Affairs Specialist (UK) in Lockington employer: ProductLife Group
At Productlife Group, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our Lockington office offers a hybrid working model, allowing for flexibility while ensuring our team members have access to ongoing professional development and mentorship opportunities. With a strong focus on employee growth and a commitment to regulatory excellence in the life sciences sector, we provide a rewarding environment where your contributions truly make a difference.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist (UK) in Lockington
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be when it comes to landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK and EU regulations. We recommend creating a list of common interview questions and practising your answers. Show them you know your stuff and are ready to tackle any regulatory challenge!
✨Tip Number 3
Don’t forget to showcase your experience with regulatory submissions! We suggest bringing examples of your past work to the interview. This will help demonstrate your expertise and give you an edge over other candidates.
✨Tip Number 4
Apply through our website for the best chance of getting noticed! We’re always on the lookout for passionate candidates who fit the bill, so make sure your application stands out by highlighting your relevant experience and skills.
We think you need these skills to ace Regulatory Affairs Specialist (UK) in Lockington
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs Specialist role. Highlight your relevant experience in regulatory submissions and compliance, and don’t forget to mention any specific knowledge of UK and EU regulations.
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 your background makes you a perfect fit for our team. Be sure to mention any experience with medical writing or liaising with regulatory authorities.
Showcase Your Attention to Detail:In regulatory affairs, attention to detail is key. When you’re filling out your application, double-check for any typos or errors. This shows us that you take pride in your work and understand the importance of accuracy in this field.
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to upload all your documents in one go. Plus, we love seeing applications come directly from our site!
How to prepare for a job interview at ProductLife Group
✨Know Your Regulations
Make sure you brush up on UK and EU regulatory frameworks before the interview. Familiarise yourself with the specific regulations that apply to the role, as this will show your potential employer that you're serious about the position and understand the landscape you'll be working in.
✨Showcase Your Experience
Prepare to discuss your past experiences in Regulatory Affairs, especially any relevant projects you've worked on. Be ready to provide examples of how you've successfully navigated regulatory submissions or liaised with authorities, as this will demonstrate your capability and confidence in the role.
✨Ask Insightful Questions
Interviews are a two-way street! Prepare thoughtful questions about the company's regulatory processes, team dynamics, and future projects. This not only shows your interest but also helps you gauge if the company is the right fit for you.
✨Highlight Your Communication Skills
Since the role requires excellent communication skills, be prepared to showcase how you've effectively communicated complex regulatory information in the past. Whether it's through writing reports or presenting to stakeholders, share specific instances where your communication made a difference.
