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- Aufgaben: Join us as a Regulatory Affairs Executive to manage regulatory documents and submissions for the EU market.
- Arbeitgeber: Be part of a global organization that values diversity and collaboration in a dynamic work environment.
- Mitarbeitervorteile: Enjoy a competitive salary, health insurance, and opportunities for career growth and advancement.
- Warum dieser Job: This role offers a chance to make an impact while working with authorities and supporting project teams.
- Gewünschte Qualifikationen: Must have a Master's or higher degree in a science-related field and strong coordination skills.
- Andere Informationen: Work hours are from 8 AM to 5 PM, perfect for balancing studies and work.
Das voraussichtliche Gehalt liegt zwischen 36000 - 60000 € pro Jahr.
Salary:
Competitive
Job Timings:
8 AM to 5 PM
Requirements:
Graduation in pharmacy background or any relevant degree.
About the role:
- To contribute to the regulatory documents and reports to be included in regulatory submission.
- Documents and track regulatory submission and regulatory authority license approval for EU market and most probably Germany.
- Provide regulatory support to the teams and associates of the company.
Responsibilities:
- Application for new registration to receive license from EMA.
- Cooperation with authorities (e.g. BfArM, PEI, EMA, EC).
- New registrations/manufacturer sampling electronic PI submissions.
- Create sample packaging (outer packaging, labels, package insert).
- Create manufacturing instructions as per EU legislation and receipt of approval from MAH.
- Maintenance of existing approvals and maintaining formats and content review of packaging texts, SmPC, PIL and labelling.
- Review task for, support and mentor Regulatory Affairs associates.
- Provide on-going regulatory support to the regulatory affairs team lead and to project teams to ensure regulatory concerns are planned and accounted for the relevant data are generated to meet project objectives.
- Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflet and labelling.
- Contribute to data entry in softwares, Control that invoicing is correctly done.
- 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 skills and leadership.
- Excellent organizational and interpersonal skills.
- confident use of MS Office and Multi-tasking.
- Effective oral and written communicational skills.
- Proactive attitude and able to work on own initiative as well as part of team.
- Ability to prioritized different workloads/multi tasks.
- 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.
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Regulatory Affairs Executive Arbeitgeber: to Beauty Care Global
Kontaktperson:
to Beauty Care Global HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Regulatory Affairs Executive
✨Tip Number 1
Familiarize yourself with the regulatory landscape in the EU, especially focusing on Germany. Understanding the specific requirements of authorities like BfArM and EMA will give you an edge during discussions and interviews.
✨Tip Number 2
Highlight any experience you have with regulatory submissions or working with regulatory documents. Be prepared to discuss specific examples where you contributed to successful submissions or compliance efforts.
✨Tip Number 3
Showcase your organizational and multitasking skills by preparing examples of how you've managed multiple projects or tasks simultaneously. This is crucial for the role, as it involves handling various regulatory responsibilities.
✨Tip Number 4
Demonstrate your proactive attitude by discussing instances where you took the initiative to solve problems or improve processes in previous roles. This will align well with our expectations for a candidate who can work independently and as part of a team.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Regulatory Affairs Executive
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Regulatory Affairs Executive position. Highlight key responsibilities and requirements that align with your skills and experiences.
Tailor Your CV: Customize your CV to reflect your pharmacy background or relevant degree. Emphasize your experience in regulatory submissions, cooperation with authorities, and any leadership roles you've held.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your understanding of regulatory affairs and your proactive attitude. Mention specific examples of how you've contributed to regulatory processes in previous roles.
Highlight Communication Skills: Since effective oral and written communication is crucial for this role, provide examples in your application that demonstrate your strong communication skills, especially in a regulatory context.
Wie du dich auf ein Vorstellungsgespräch bei to Beauty Care Global vorbereitest
✨Show Your Regulatory Knowledge
Make sure to brush up on your knowledge of regulatory affairs, especially regarding the EMA and BfArM. Be prepared to discuss specific regulations and how they apply to the role.
✨Demonstrate Your Organizational Skills
Since the role requires excellent organizational skills, be ready to provide examples from your past experiences where you successfully managed multiple tasks or projects simultaneously.
✨Highlight Your Communication Skills
Effective communication is key in this position. Prepare to discuss how you've effectively communicated with teams or authorities in the past, and be ready to showcase your written communication skills.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving abilities in regulatory contexts. Think about challenges you've faced and how you overcame them, particularly in relation to regulatory submissions.
