Senior Regulatory Lead EU/ROW
2 days ago
Job Description:
The Senior Regulatory Lead EU/ROW will be responsible for ensuring regulatory oversight and progress of clinical trial submissions in the EU/ROW region. This role will represent RA in the Clinical Trial Teams and work closely with CROs and internal stakeholders to ensure compliance with regulatory requirements.
Key Responsibilities:
- Represent RA in the Clinical Trial Teams and ensure oversight and progress of multiple, often highly complex, clinical trial submission activities.
- Develop and execute the EU/ROW regulatory strategy for assigned projects.
- Prepare strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, etc.
- Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management.
Requirements:
- A minimum of Bachelor's degree or equivalent in a scientific discipline or health-related field.
- Minimum of 8 years of experience in Regulatory Affairs, preferably in development phase up to and including submission of global marketing authorization applications.
- Strong project management skills and ability to lead multiple ongoing projects simultaneously.
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