Clinical Regulatory Professional
Há 2 dias
Job Title: Regulatory Specialist
About the RoleWe are seeking a highly skilled and experienced Regulatory Specialist to join our team. The ideal candidate will have a strong background in regulatory affairs, excellent communication skills, and the ability to work effectively in a fast-paced environment.
Key Responsibilities:- Maintain awareness of regulatory legislation, guidance, and practice in assigned countries.
- Coordinate data and information collection for EC/IRB/Third body/Regulatory Authority submissions.
- Compile routine submission files to IRB/IEC/Third body/Regulatory Authorities and liaise with them regarding submission/approval.
- Liaise with internal and external vendors in generating Regulatory Authority submissions.
- Perform review of final submission documents as applicable.
- Ensure all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget, and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs, and quality standards.
- Prevent and escalate study issues appropriately and in a timely fashion.
- Serve as primary contact for investigative sites and ensure necessary documents are collected in a timely manner.
- Collect and track all necessary documents, perform a quality review, formatting, and compilation of final documents for effective and compliant site activation and maintenance.
- Ensure high-quality documents are filed and systems are updated on an ongoing and timely basis, making us ready for an audit at any time.
- Participate in team and project meetings as applicable.
- Assist in the strategy definition for Site Activation and provide accurate projections and timelines to study teams.
- Review and customize country- and site-specific patient informed consent forms for compliance with local requirements and protocol.
- Proactively resolve informed consent issues and other potential difficulties with study sites.
- Support negotiation of site contracts and budgets with sites, if applicable, and track progress of contract and budget milestones/developments.
- Proactively identify and escalate to Submission Leads any risk to meeting deliverables.
- Assist in uploading submission documentation to CTIS and interact with and monitor notifications and alerts to ensure all milestones and events for the trial are met within mandated timelines.
- Minimum 3 years of experience in regulatory affairs or a related field.
- Degree in Life Sciences, Law, or a related field.
- Excellent written and verbal communication skills.
- Able to work independently and as part of a team.
- Familiarity with regulatory requirements and guidelines.
- Strong organizational and problem-solving skills.
- Ability to maintain confidentiality and handle sensitive information.
- Competitive salary and benefits package.
- Opportunities for career growth and professional development.
- Collaborative and dynamic work environment.
- Flexible working hours and remote work options.
We are a leading provider of clinical research services, dedicated to delivering high-quality solutions that meet the needs of our clients. Our team is passionate about innovation and excellence, and we are committed to building long-term relationships with our partners.
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