Senior Regulatory Information Management & Innovation Specialist- Contract - Remote
Ready to shape your future with the freedom to work where you thrive? Join our client with this fully remote position that fits into your life!
Proclinical is seeking a Senior Regulatory Information Management & Innovation Specialist.
Primary Responsibilities:
This position focuses on managing regulatory registration details, ensuring data quality, and supporting the archival of global regulatory documents. You will play a key role in maintaining compliance and assisting with regulatory systems projects.
Skills & Requirements:
- Strong attention to detail and ability to manage data quality.
- Experience in regulatory affairs or related fields is highly preferred.
- Familiarity with regulatory systems and processes.
- Ability to assist with audits, inspections, and procedural documentation.
- High school diploma or equivalent with relevant experience.
The Senior Regulatory Information Management & Innovation Specialist's responsibilities will be:
- Manage RIM registration details, including building and maintaining master and transactional data records.
- Monitor and ensure ongoing data quality, compliance, and timely remediation.
- Archive global regulatory health authority interactions, such as approval letters, meeting minutes, and acknowledgment letters.
- Oversee the process for transferring submissions to partners.
- Archive legacy submissions and correspondences.
- Gather information for submission exchanges with new or potential partners.
- Assist in reviewing and developing departmental procedural documents in line with agency regulations and guidance.
- Support audit and inspection activities by retrieving regulatory information.
- Participate in regulatory systems projects, including system validation activities.
- Identify and communicate regulatory system enhancement needs or technical issues.
- Reinforce core RIM data rules and processes across the business.
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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