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Senior Regulatory Operations Specialist
2 semanas atrás
We are a leading healthcare intelligence and clinical research organization, driven by our people to shape the future of clinical development. Our diverse teams enable us to become a better partner to our clients and patients at every touch-point.
We prioritize accountability, collaboration, partnership, and integrity in everything we do. We strive to be a Clinical Research Organisation that delivers excellence to our clients and patients at every stage.
We are currently seeking a Senior Regulatory Operations Associate to join our dynamic team. As a key member, you will play a pivotal role in managing regulatory documents and processes, contributing to the successful execution of clinical trials.
Your Key Responsibilities:
- Lead the preparation, compilation, and submission of regulatory documents for clinical trials.
- Manage electronic document management systems (eTMF, eCTD) to ensure compliance and accessibility of regulatory documents.
- Support internal stakeholders with regulatory operations processes and provide guidance as needed.
- Collaborate with cross-functional teams to ensure timely completion of regulatory deliverables.
- Monitor and optimize regulatory operations processes to improve efficiency and compliance.
Your Profile:
- A Bachelor's degree in a scientific or related field; an advanced degree is preferred.
- A minimum of 3 years of experience in regulatory operations within the pharmaceutical or biotech industry.
- Proficiency in electronic document management systems (eTMF, eCTD) and regulatory submission software.
- A strong understanding of regulatory requirements and guidelines for clinical trials.
- Excellent organizational, communication, and problem-solving skills.
We offer competitive compensation packages and comprehensive benefits, including annual bonuses, health insurance, retirement plans, and more. Join us to drive lasting change and advance patient care.
