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- Tasks: Join us as a Regulatory Affairs Executive, ensuring compliance for diverse products.
- Company: Be part of a dynamic consulting company focused on regulatory excellence.
- Benefits: Enjoy a full-time role with opportunities for growth and development.
- Why this job: Make an impact in the pharmaceutical industry while working with innovative teams.
- Qualifications: 3 years of experience in regulatory affairs and strong communication skills required.
- Other info: Ideal for detail-oriented individuals looking to kickstart their career in a supportive environment.
The predicted salary is between 30000 - 42000 £ per year.
We are seeking a highly motivated and detail-oriented RA Executive to join our consulting company. The successful candidate will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of clients' products across the UK and Europe, with a primary focus on the UK, covering human and veterinary medicines, medical devices, biocides, cosmetics, general products, and supplements.
Key Objectives
- Complete regulatory and technical work as required for various product categories, including human and veterinary medicines, medical devices, biocides, cosmetics, general products, and supplements.
- Communicate effectively with regulatory authorities and notified bodies.
- Contribute to process improvements within the Regulatory team.
Principal Responsibilities
- Independently prepare regulatory submissions for medicinal products, including but not limited to new license applications, variations, responses to questions, and renewals.
- Coordinate and review technical documentation.
- Support regulatory compliance for medical devices.
- Author sections of Module 3 of dossiers and Quality Overall Summaries.
- Provide technical support within the regulatory framework.
- Participate in regulatory team meetings, manage assigned tasks/projects, and provide regular updates.
- Use and update regulatory information systems to plan, prepare, track, and store submissions to regulatory agencies.
- Undertake any other duties reasonably associated with this position as assigned by the Board of Directors.
Experience
- 3 years of relevant experience in regulatory affairs, specifically within the UK and European regulations.
- Experience managing artwork generation, labeling, and updates to product information.
- Hands-on experience with MLA, MAA, CTD, Variations, Renewals, Labeling, MAH Applications.
- Familiarity with software packages and databases such as Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat, etc.
- Strong organizational and communication skills.
- Ability to prioritize and deliver high-quality work efficiently.
Regulatory Affairs Executive employer: ProductLife Group
Contact Detail:
ProductLife Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Executive
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks in the UK and Europe. Understanding the nuances of regulations for human and veterinary medicines, medical devices, and other product categories will give you a significant edge during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs field. Attend industry events or join relevant online forums to connect with others who can provide insights or even refer you to opportunities at companies like ours.
✨Tip Number 3
Stay updated on the latest trends and changes in regulatory affairs. Subscribe to newsletters or follow key organisations on social media to demonstrate your commitment to continuous learning during your discussions with us.
✨Tip Number 4
Prepare to discuss your hands-on experience with regulatory submissions and software tools. Be ready to share specific examples of how you've managed projects or improved processes in previous roles, as this will showcase your practical knowledge.
We think you need these skills to ace Regulatory Affairs Executive
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly within the UK and European regulations. Emphasise any specific projects or roles that align with the responsibilities outlined in the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your motivation for applying to this role. Discuss your understanding of regulatory compliance and how your skills can contribute to the company's objectives. Be sure to mention any specific experiences that relate to the job.
Highlight Technical Skills: In your application, clearly outline your familiarity with relevant software packages and databases such as Microsoft Office Suite, Veeva Vault, and others mentioned in the job description. This will demonstrate your readiness for the technical aspects of the role.
Showcase Communication Skills: Since effective communication with regulatory authorities is crucial, provide examples in your application that illustrate your strong organisational and communication skills. This could include experiences where you successfully managed projects or collaborated with teams.
How to prepare for a job interview at ProductLife Group
✨Know Your Regulations
Familiarise yourself with the specific regulatory requirements for human and veterinary medicines, medical devices, and other products relevant to the role. Being able to discuss these regulations confidently will show your expertise and commitment to compliance.
✨Prepare for Technical Questions
Expect questions about your experience with regulatory submissions, such as MLA, MAA, and CTD. Be ready to provide examples of past projects where you successfully managed these processes, highlighting your attention to detail and organisational skills.
✨Showcase Communication Skills
Since effective communication with regulatory authorities is key, prepare to demonstrate your ability to convey complex information clearly. You might be asked how you would handle a challenging conversation with a regulatory body, so think of examples that showcase your diplomatic skills.
✨Discuss Process Improvements
Be prepared to talk about any process improvements you've implemented in previous roles. This could include how you streamlined submission processes or improved documentation practices, which will illustrate your proactive approach and ability to contribute to the team.
