10 oct
|
Icon Clinical Research
|
México
10 oct
Icon Clinical Research
México
Home based role in Mexico
ICON is a general healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
As a Senior Global Regulatory Scientist at ICON, you will provide high-level regulatory and scientific expertise to support global development strategies and submissions.
What You Will Do:
Your experience in regulatory affairs will be key in delivering high-quality outcomes and mentoring colleagues.
Key responsibilities include:
- Leading the development of global regulatory strategies for clinical programmes, including plans for key health authority interactions and milestones.
- Authoring and reviewing complex regulatory documents such as clinical trial applications, briefing books, and major submission components.
- Interpreting evolving global regulations, guidelines, and precedents,
and advising teams on implications for programme design and execution.
- Providing strategic input into clinical development plans, risk management strategies, and labelling considerations.
- Representing regulatory functions in sponsor and health authority meetings, ensuring clear, scientifically robust communication.
- Mentoring junior regulatory colleagues and contributing to internal best practices, templates, and knowledge-sharing initiatives.
Your Profile:
You will have a strong foundation in regulatory affairs, with the experience to work independently and guide others.
Required qualifications and experience:
- Bachelor's degree in a relevant scientific discipline or healthcare-related field
- Extensive experience in regulatory affairs or regulatory science within pharma, biotech, or CRO environments.
- Strong knowledge of global clinical development regulations (e.g., FDA, EMA, ICH) and regional requirements.
- Ex
📌 Senior Global Regulatory Scientist (México)
🏢 Icon Clinical Research
📍 México