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- Tasks: Join us as a Regulatory Affairs Executive, managing submissions and supporting teams.
- Company: Be part of a global organisation dedicated to regulatory excellence in the pharmaceutical industry.
- Benefits: Enjoy a competitive salary, health insurance, and career growth opportunities.
- Why this job: Make an impact in a dynamic, inclusive environment while developing your regulatory expertise.
- Qualifications: Master’s degree in a science-related field with strong coordination and communication skills required.
- Other info: Work hours are 8 AM to 5 PM, perfect for balancing studies and work.
The predicted salary is between 28800 - 48000 £ per year.
Salary: Competitive
Job Timings: 8 AM to 5 PM
Requirements: Graduation in pharmacy background or any relevant degree.
About the Role:
- Contribute to regulatory documents and reports for regulatory submission.
- Document and track regulatory submissions and regulatory authority license approvals for the EU market, particularly Germany.
- Provide regulatory support to the teams and associates of the company.
Responsibilities:
- Apply for new registrations to receive licenses from EMA.
- Cooperate with authorities (e.g., BfArM, PEI, EMA, EC).
- Manage new registrations and manufacturer sampling electronic PI submissions.
- Create sample packaging (outer packaging, labels, package insert).
- Create manufacturing instructions as per EU legislation and obtain approval from MAH.
- Maintain existing approvals and review formats and content of packaging texts, SmPC, PIL, and labeling.
- Review tasks, support, and mentor Regulatory Affairs associates.
- Provide ongoing regulatory support to the regulatory affairs team lead and project teams to ensure regulatory concerns are addressed and relevant data is generated to meet project objectives.
- Conduct format and content reviews of packaging texts, Summary of Product Characteristics, Patient Information Leaflet, and labeling.
- Contribute to data entry in software, ensuring accurate invoicing.
- Assist the RA platform or hub leader or Coordinator in presales.
Candidate Requirements:
- Master’s or higher graduate degree in a science-related field.
- Strong coordination and leadership skills.
- Excellent organizational and interpersonal skills.
- Confident use of MS Office and ability to multitask.
- Effective oral and written communication skills.
- Proactive attitude and ability to work independently as well as part of a team.
- Ability to prioritize different workloads and multitask.
- Personal responsibility for ensuring a high standard of work.
Benefits:
- Competitive salary and performance-based incentives.
- Comprehensive benefits package including health insurance.
- Opportunities for career growth and advancement within a global organization.
- Dynamic and collaborative work environment with a diverse and inclusive culture.
Contact Detail:
Astute Healthcare Ltd. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Executive
✨Tip Number 1
Familiarise yourself with the regulatory landscape in the EU, especially focusing on Germany. Understanding the specific requirements and processes of authorities like BfArM and EMA 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 StudySmarter.
✨Tip Number 3
Brush up on your MS Office skills, particularly Excel and PowerPoint, as these tools are essential for managing data and creating presentations. Being proficient will demonstrate your readiness to handle the responsibilities of the role.
✨Tip Number 4
Prepare to discuss your experience with regulatory submissions and document management. Be ready to share specific examples of how you've contributed to similar projects, as this will showcase your practical knowledge and problem-solving abilities.
We think you need these skills to ace Regulatory Affairs Executive
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your pharmacy background and any relevant experience in regulatory affairs. Use keywords from the job description to demonstrate that you meet the requirements.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the responsibilities of the Regulatory Affairs Executive role. Mention your experience with regulatory submissions and your ability to work with authorities like EMA and BfArM.
Showcase Your Skills: In your application, emphasise your strong coordination, leadership, and organisational skills. Provide examples of how you've successfully managed multiple tasks or projects in the past.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Astute Healthcare Ltd.
✨Know Your Regulations
Familiarise yourself with the key regulatory bodies and their requirements, especially those relevant to the EU market like EMA, BfArM, and PEI. Being able to discuss these regulations confidently will show your expertise and preparedness for the role.
✨Showcase Your Organisational Skills
Prepare examples of how you've managed multiple projects or tasks in the past. Highlight your ability to prioritise workloads and maintain high standards, as this is crucial for a Regulatory Affairs Executive.
✨Demonstrate Team Collaboration
Be ready to discuss your experience working in teams and how you’ve supported colleagues in achieving regulatory goals. Emphasising your interpersonal skills will be key, as collaboration is essential in this role.
✨Prepare for Technical Questions
Expect questions related to regulatory submissions, packaging texts, and licensing processes. Brush up on your technical knowledge and be prepared to explain how you would approach specific regulatory challenges.
