Senior Clinical Trials Regulatory Expert
2 weeks ago
Job Overview
This role is for a highly skilled and experienced Senior Clinical Trials Regulatory Expert to join our team at IQVIA.
We are seeking an individual who can provide strategic support for complex clinical trial projects and programs, ensuring compliance with regulatory requirements.
Key Responsibilities
- Act as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs.
- Independently review and prepare regulatory documents to support clinical trial submissions.
- Develop and maintain knowledge of global regulations, directives, and guidance supporting clinical research and development.
- Collaborate with cross-functional teams to ensure seamless execution of clinical trials.
- Provide regulatory training and presentations as required.
Requirements
- Minimum 5 years' experience in a similar role, preferably within the pharmaceutical or CRO industry.
- Degree in life science-related discipline or professional equivalent.
- EU-CTR and Global CTA submission experience.
- Strong understanding of regulatory requirements and ability to apply this knowledge in a fast-paced environment.
- Excellent communication and negotiation skills.
Salary and Benefits
The estimated salary for this position is $120,000 - $180,000 per year, depending on experience and qualifications.
In addition to the competitive salary, we offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
Working Conditions
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Regular sitting for extended periods of time.
- Travel might be required.
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