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Senior Regulatory Affairs Specialist
hace 2 meses
We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at ICON plc. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the successful execution of clinical trials.
Key Responsibilities- Regulatory Document Preparation and Submission: Lead the preparation, submission, and maintenance of regulatory documents for clinical trials, ensuring accuracy and compliance with regulatory requirements.
- Regulatory Expertise and Guidance: Provide expertise and guidance on regulatory requirements and standards to internal teams, ensuring seamless collaboration and compliance.
- Regulatory Agency Interface: Interface with regulatory agencies to address inquiries, submissions, and approvals, ensuring timely and effective communication.
- Regulatory Monitoring and Compliance: Monitor changes in regulations and guidelines to ensure compliance and mitigate risks, ensuring our clinical trials are conducted in accordance with the latest regulatory standards.
- Cross-Functional Collaboration: Collaborate with cross-functional teams to support regulatory aspects of clinical trial planning and execution, ensuring a seamless and compliant process.
- Education: Bachelor's degree in a scientific or related field; advanced degree preferred.
- Experience: Minimum of 2 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
- Regulatory Knowledge: Strong knowledge of global regulatory requirements and guidelines for clinical trials.
- Regulatory Management: Proven ability to manage regulatory submissions and interactions with regulatory agencies.
- Communication and Problem-Solving Skills: Excellent communication, attention to detail, and problem-solving skills.
- Language Skills: Advanced English for Reading / Writing / Speaking.
- Desirable Skills: e-systems knowledge on CTMS, PhlexEview, PSO, BOX.
We offer a competitive salary and a range of benefits designed to support your well-being and work-life balance, including various annual leave entitlements, health insurance offerings, competitive retirement planning, and more.
We are an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment. We welcome applications from diverse candidates and are committed to creating an inclusive environment that values diversity and promotes equal opportunities.
