Regulatory Affairs Specialist
hace 5 días
Syneos Health is a leading provider of biopharmaceutical solutions, dedicated to accelerating customer success through clinical, medical affairs, and commercial insights.
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory department, you will be responsible for ensuring compliance with applicable regulations and guidelines in the conduct of clinical trials.
Key Responsibilities- Collaborate with cross-functional teams to identify and evaluate regulatory issues related to site activation.
- Participate in strategic development activities, including client meetings and account planning.
- Provide leadership and guidance to staff members, including interviewing, selection, job description preparation, professional development, goal setting, performance management, coaching, and mentoring.
- Maintain strategic relationships with clients, assessing their needs and ensuring project deliverables meet internal and external expectations.
- Work closely with project leadership to define strategies for executing against milestones and key deliverables.
- Prepare and present overall regulatory strategy and status at client meetings.
- Coordinate and perform regulatory core submissions, tracking study-level submission packages.
- Act as liaison and facilitator between client leaders and senior management on regulatory tasks and issues.
- Stay up-to-date with applicable regulations and guidelines.
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