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- Tasks: Contribute to regulatory documents and support teams in the EU market.
- Company: Global organisation with a dynamic and inclusive culture.
- Benefits: Competitive salary, health insurance, and career growth opportunities.
- Why this job: Make an impact in regulatory affairs while working in a collaborative environment.
- Qualifications: Master's degree in a science-related field and strong leadership skills.
- Other info: Join a diverse team and enjoy a supportive work atmosphere.
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.
Regulatory Affairs Executive in London employer: Astute Healthcare Ltd.
Contact Detail:
Astute Healthcare Ltd. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Executive in London
✨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 researching the company and its regulatory processes. We recommend practising common interview questions related to regulatory affairs, so you can showcase your knowledge and confidence when it counts.
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can leave a lasting impression. We believe this shows your enthusiasm for the role and keeps you fresh in their minds.
✨Tip Number 4
Apply through our website for the best chance of getting noticed! We make it easy for you to submit your application directly, ensuring it lands in the right hands. Plus, it shows you’re serious about joining our team!
We think you need these skills to ace Regulatory Affairs Executive in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the Regulatory Affairs Executive role. Highlight your pharmacy background and any relevant regulatory experience to catch our eye!
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 at StudySmarter.
Showcase Your Communication Skills: Since effective communication is key in this role, make sure your application is clear and concise. Use proper formatting and check for any typos – we love attention to detail!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role without any hiccups!
How to prepare for a job interview at Astute Healthcare Ltd.
✨Know Your Regulations
Make sure you brush up on the key regulations and guidelines relevant to the EU market, especially those pertaining to Germany. Familiarise yourself with the roles of authorities like EMA, BfArM, and PEI, as this knowledge will show your commitment and understanding of the regulatory landscape.
✨Showcase Your Organisational Skills
Since the role requires excellent organisational skills, prepare examples from your past experiences where you successfully managed multiple tasks or projects. Be ready to discuss how you prioritised workloads and ensured high standards in your work.
✨Communicate Effectively
Practice articulating your thoughts clearly and concisely. Given the importance of effective oral and written communication in this role, consider preparing a brief presentation on a relevant topic to demonstrate your ability to convey complex information simply.
✨Demonstrate Team Spirit
This position involves working closely with various teams, so be prepared to discuss how you've collaborated in the past. Share specific instances where you supported colleagues or mentored others, highlighting your proactive attitude and teamwork skills.