Regulatory Affairs Consultant
Mexico, Remote 求人ID R0000025517 Category Regulatory / ConsultingAbout this Role
We are currently recruiting for two Regulatory Affairs Consultant / Leads roles, one located in Mexico and the other located multi-country (Argentina o Peru or Brazil). As Regulatory Affairs Consultant / Leads, these individuals will play a pivotal role in supporting our global strategies and ensuring compliance with local regulations in their respective regions.
Skills and experience:
- More than 06 years in the Clinical Trial Regulatory Area.
- Having experience in leading projects at the global regulatory level.
- Having experience leading the regulatory team and coordinating the compilation of the Core dossiers to be submitted by the SMEs to several countries worldwide from end to end.
- Experience in Central America countries will be value, but it's not mandatory.
- Knowledge of EU-CTR 536/2014 (ideal).
- Coordinate and manage the flow of information, track project progress, and identify and solve problems in a team-oriented environment.
- Reviews of critical key technical documents (e.g. clinical trial protocols and reports, study drug labels, and other clinical trial-related technical documentation) to ensure regulatory compliance for clinical trial applications, consistency with other key documents and ease of review.
- Interface with the project team and the regulatory authorities on regulatory and technical matters, as appropriate.
- Support the sponsor for the development of optimized clinical trial submission strategies.
- Project management knowledge.
- Advanced written and Speaking English.
- Client-focused approach to work.
- Results orientation.
- Teamwork and collaboration skills Consulting skills.
- Excellent interpersonal and intercultural communication skills, both written and verbal.
- Critical thinking and problem-solving skills.
- Proficiency in the local language.
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