Global Regulatory Specialist Leader
hace 2 días
This role offers a unique opportunity to lead the regulatory strategy for clinical trials in Mexico City, collaborating with local study teams to ensure seamless execution. Key responsibilities include:
- Developing and implementing submissions strategies for studies across various therapeutic areas.
- Providing expert insights to study teams to optimize regulatory and ethics committee submissions.
- Collaborating with local teams to ensure accurate planning, prioritization, risk mitigation, and timely issue resolution.
- Preparing and reviewing documentation required for regulatory processes, including ethics committees and Ministry of Health submissions.
- Staying up-to-date with regulatory changes and submission requirements through connections with local experts and participation in external think tanks and agencies.
The ideal candidate will have a strong background in Mexican regulations for clinical research, excellent written and verbal communication skills in English and Spanish, and experience working in a dynamic environment with constantly evolving processes and systems. A bachelor's degree or equivalent is required, with an MBA being preferred. The salary for this position is estimated to be around $120,000-$150,000 per year, depending on qualifications and experience.
Why GSK?GSK is a global biopharma company dedicated to uniting science, technology, and talent to get ahead of disease together. We focus on preventing and treating disease with vaccines, specialty and general medicines, and invest in four core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology. Our success depends on our people, and we strive to create an inclusive and inspiring work environment where individuals can thrive and grow. Join us at this exciting moment in our journey to make a meaningful impact in the lives of patients worldwide.
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