
Regulatory Compliance Specialist
3 days ago
About Us:
At Minerva Research Solutions, we are dedicated to transforming the landscape of healthcare and research through our quality clinical services. Our company aims to support the biotech, medical, and pharma industries by providing comprehensive solutions for all phases of the clinical trial lifecycle.
We offer a range of services, including Data Operation, Recruitment Services, and Regulatory. Our goal is to deliver high-quality data and solutions that enable clients to speed up the lifecycle of novel therapies. We follow stringent FDA and GCP regulations throughout all phases of the clinical trial process.
Job Overview:
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.
- BUILDING AND 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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