Regulatory Affairs Consultant

at  Parexel

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.

Please refer the Job description for details