Sunstone Therapies
Regulatory Affairs Specialist
Rockville, MD
·
Full time
The Regulatory Affairs Specialist will have contact with the FDA, Pharmaceutical companies, Contract Research Organizations (CROs), Institutional Review Boards, community organizations, and Sunstone staff. Under direct supervision and guidance of the Research Manager, the Specialist is responsible for the planning, execution and successful management of regulatory affairs, quality oversight and data management pertaining to all clinical research activities
Description
Core duties include:
- Assist with design ,and maintain centralized regulatory intelligence database that facilitates the management of all active, preparatory and archived clinical study regulatory and quality related activities
- Manage and evaluate company-wide ICH-GCP Standard Operating Procedures (SOPs)/ and associated quality and and data processes
- Develop, Train, Manage, and evaluate systems associated with regulatory affairs, quality oversight and data management
- Conduct ongoing research and analysis on current federal, state and local laws/regulations pertaining to Sunstone operations
- Develop quality control measures, including ongoing internal quality review of processes related to regulatory compliance and data integrity
- Collect, file and enter data in multiple platforms including sponsor edc systems and Sunstones EHR
To be successful in the role the incumbent must have:
- BS in related field/ comparable experience is required
- 2+ years clinical trial research experience in regulatory and quality assurance is required
- A high level of computer/ software proficiency
- Meticulous attention for detail and strong organizational skills
- Interpersonal skills, the ability to communicate complex data in a clear way, in both written and verbal communication
- Ability to demonstrate knowledge and skill in techniques of regulatory affairs and good clinical judgment
- A team player attitude
- Ability to prioritize projects and meet deadlines