
Global Regulatory Affairs Manager
4 days ago
Our Mission:
At Minerva Research Solutions, we strive to transform the landscape of healthcare and research through our quality clinical services. Our mission is to deliver high-quality data and solutions that enable clients to speed up the lifecycle of novel therapies.
Job Summary:
The Regulatory Coordinator will work as a team member of regulatory professionals to ensure regulatory compliance of company products and activities. This includes preparing and submitting regulatory documents, managing regulatory inspections, and developing regulatory strategies.
Key Responsibilities:
- Providing effective and efficient regulatory support for the company's products and activities.
- Developing and implementing regulatory strategies that support the company's business objectives and ensure compliance with relevant regulations and guidelines.
- Preparing and submitting regulatory documents, including filings, registrations, and certifications.
- Coordinating and managing regulatory inspections and audits, and ensuring appropriate corrective actions are taken in response to any findings.
- Staying up-to-date on changes in regulatory requirements and guidelines, and communicating these changes to relevant stakeholders.
- Maintaining positive relationships with regulatory authorities and other external stakeholders.
- Providing regulatory guidance and support to cross-functional teams, including product development, clinical research, manufacturing, and quality assurance.
- Collaborating with internal and external stakeholders to develop and implement regulatory policies and procedures that support the company's overall goals and objectives.
- Ensuring timely and accurate reporting of regulatory activities and metrics.
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