Regulatory Compliance Specialist
hace 1 mes
MEX Labcorp Clinical Development, S. de R.L. de C.V. is seeking a highly motivated Regulatory Compliance Specialist to join our team. As a key member of our clinical development team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the assigned countries.
Key Responsibilities:
- Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries.
- Coordinate, collect, and organize data and information required by EC/IRB/Third body/Regulatory Authority.
- Compile and prepare routine submission files to IRB/IEC/Third body/Regulatory Authorities.
- Liaise with internal and external vendors in the generation of Regulatory Authority submissions.
- Perform a review of final submission documents.
- Ensure that 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.
Requirements:
- Strong knowledge of regulatory requirements and guidelines in the assigned countries.
- Excellent communication and organizational skills.
- Ability to work independently and as part of a team.
- Proficiency in Microsoft Office and clinical trials management systems.
What We Offer:
- A competitive salary and benefits package.
- Opportunities for professional growth and development.
- A dynamic and collaborative work environment.
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