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- Tasks: Help create and manage regulatory documents for the EU market, especially Germany.
- Company: Join a global organisation focused on innovation in the pharmaceutical industry.
- Benefits: Enjoy competitive pay, health insurance, and career growth opportunities.
- Why this job: Be part of a dynamic team making a real impact in healthcare regulations.
- Qualifications: Must have a Master’s degree in a science-related field and strong organisational skills.
- Other info: Work hours are 8 AM to 5 PM, with a collaborative and inclusive culture.
The predicted salary is between 30000 - 42000 £ 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 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
✨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 an 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 referrals for positions 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 for 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 in the past, showcasing your proactive attitude and teamwork.
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. Emphasise your skills in documentation, coordination, and communication, as these are crucial for the role.
Craft a Strong Cover Letter: Write a cover letter that specifically addresses the responsibilities mentioned in the job description. Explain how your previous experiences align with the tasks of managing regulatory submissions and working with authorities.
Highlight Relevant Skills: In your application, focus on your organisational skills, ability to multitask, and experience with MS Office. Provide examples of how you've successfully managed multiple projects or collaborated with teams in the past.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors. A well-presented application reflects your attention to detail, which is essential 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 specific regulations and how they impact the role will show your expertise and preparedness.
✨Showcase Your Communication Skills
As a Regulatory Affairs Executive, effective communication is crucial. Prepare examples of how you've successfully communicated complex information to different stakeholders. This will demonstrate your ability to convey important regulatory details clearly.
✨Demonstrate Organisational Skills
Be ready to discuss how you manage multiple tasks and priorities. Share specific instances where your organisational skills led to successful project outcomes, particularly in regulatory submissions or documentation.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving abilities in regulatory contexts. Think about past experiences where you had to navigate challenges in regulatory processes and be prepared to explain your thought process and actions.
