
Clinical Trials Regulatory Coordinator
3 days ago
About Minerva Research Solutions:
We are a clinical trial management service provider committed to delivering high-quality data and solutions to make your clinical trials a success. Our team follows stringent FDA and GCP regulations throughout all phases of the clinical trial process.
Job Purpose:
The Coordinator - Regulatory Affairs 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:
- Working closely with regulatory professionals to ensure 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.
- Keeping abreast of 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.
Qualifications:
- Bachelor's degree in a scientific discipline, preferably in life sciences, chemistry, or pharmacy.
- 1 year of experience in regulatory affairs, fresh graduates will also be preferred.
- In-depth knowledge of global regulatory requirements and guidelines for pharmaceuticals, medical devices, or other regulated products.
- Excellent communication, interpersonal, and problem-solving skills.
- Ability to work independently and manage multiple projects simultaneously.
- Strong attention to detail and accuracy.
- Experience working in a fast-paced, deadline-driven environment.
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