Compliance and Approval Coordinator
il y a 2 jours
We are a forward-thinking company that excels in the biotech and pharmaceutical industry. Our mission is to drive innovation through compliance and regulatory excellence, providing high-quality solutions that meet the needs of our clients.
Job Description:
We are seeking a skilled Compliance and Approval Coordinator to join our team. The successful candidate will be responsible for preparing and submitting regulatory dossiers, implementing regulatory strategies, and maintaining accurate documentation.
Key Responsibilities:
- Regulatory Dossier Preparation and Submission
- Develop and submit regulatory dossiers in compliance with all relevant guidelines and requirements.
- Regulatory Strategies and Approvals
- Implement effective regulatory strategies to secure timely approvals for our products.
- Documentation and Record Keeping
- Maintain accurate and comprehensive regulatory documentation and records.
- Communication and Collaboration
- Manage communications with regulatory health authorities regarding submissions, delivery, and formatting.
- Collaborate with internal teams to ensure seamless project execution.
- Education and Experience
- Bachelor's or Master's degree in pharmaceutical sciences, biomedical engineering, life sciences, or related fields.
- First-hand experience in a regulatory role within the biotech or pharmaceutical industry.
- Skills and Qualifications
- Proficient in regulatory dossier submissions.
- Detailed-oriented with excellent documentation skills.
- Strong team collaboration and communication skills.
- Ability to manage multiple projects and prioritize tasks effectively.
- Fluent in English and Dutch, both written and verbal; additional languages are a plus.
At MindCapture, we offer a dynamic work environment that fosters growth and development. If you're passionate about regulatory affairs and excited about the opportunity to drive innovation, join us now
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