Sr Regulatory Affairs Specialist - Remote US
About The Position
Our Senior Regulatory Affairs Specialist is responsible and accountable for coordinating the activities of physicians and the clinical team with respect to creating and maintaining required essential regulatory documents. This position ensures compliance with regulatory requirements. This position will work closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance, improve regulatory processes, and handle multiple tasks while meeting strict deadlines. The Senior Regulatory Affairs Specialist (SRAS) will have mastered the responsibilities of the Regulatory Affairs Specialist and require little to no supervision. The SRAS will carry an expanded study workload. This is a US-based remote position; relocation assistance and visa sponsorship are not available.
Requirements
- Minimum High School Diploma/GED obtained - Bachelor’s Degree or equivalent combination of education and experience may be substituted
- Minimum 3 years’ work experience in the Regulatory Affairs Specialist role
- Strong knowledge of scientific and clinical research terminology
- Knowledge of IRB, FDA, and GCP guidelines
Nice To Haves
- SOCRA Certification and/or ACRP Certification highly preferred
Responsibilities
- Maintain FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.
- Ensure all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content.
- Ensure that essential regulatory documents are created and maintained for all assigned studies.
- Ensure that these regulatory documents are completed in a timely way to meet department and sponsor timelines.
- Maintain updated physician credentials.
- Modify and/or develop informed consent forms and manages protocol and consent form modifications or amendments in compliance with IRB policy and HIPAA.
- Other duties as assigned.
Benefits
- Comprehensive benefits to support physical, mental, and financial well-being
- Competitive compensation package
- Annual bonus or long-term incentive opportunities may be offered
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
