What are the responsibilities and job description for the Regulatory Affairs Specialist position at RTI International?
Overview:
RTI International is seeking a Regulatory Affairs Specialist to perform operational duties in support of regulatory, security, and industry practices compliance documentation.
Responsibilities:
Qualifications:
EEO & Pay Equity Statements:
RTI accepts applications to our job openings from candidates with criminal histories or conviction records in accordance with all applicable laws, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
The anticipated pay range for this role is listed below. Our pay ranges represent national averages and may vary by location as a geographic differential may be applied to some locations within the United States. RTI considers multiple factors when making an offer including, for example: established salary range, internal budget, business needs, and education and years of work experience possessed by the applicant. Further, salary is merely one element to our offer.
At RTI, we demonstrate our commitment to rewarding individual and team achievement through a total rewards package. This package includes (among other things) a competitive base salary, a generous paid time off policy, merit based annual increases, bonus opportunities and a robust recognition program. Other benefits include a competitive range of insurance plans (including health, dental, life, and short-term and long-term disability), access to a retirement savings program such as a 401(k) plan, paid parental leave for all parents, financial assistance with adoption expenses or infertility treatments, financial reimbursement for education and developmental opportunities, an employee assistance program, and numerous other offerings to support a healthy work-life balance.
Hiring Salary Range: $59,000-$73,000
RTI International (RTI) is both a global research institute and a leading international development organization. We combine these powerful capabilities with those of our partners to co-create smart, shared solutions for a more prosperous, equitable, and resilient world. Based in North Carolina, USA, RTI is one of the top implementing partners of projects funded through the U.S. Agency for International Development (USAID). A commitment to making meaningful change energizes our 6,000 staff who deliver results across eight international development sectors and in more than 80 countries.
RTI International is seeking a Regulatory Affairs Specialist to perform operational duties in support of regulatory, security, and industry practices compliance documentation.
- Performs operational duties in support of regulatory, security, and industry practices compliance documentation.
Coordinates receiving and delivery of RTI intellectual property in order to maintain and track document chain-of-custody.
Serves as backup support for electronic data/document management & quality management system.
Manages process for creation, revision, and retirement/archive of intellectual property and controlled documents, including research-related outputs, standard operating procedures, and training records.
Supports physical records digitization efforts in collaboration with external vendor.
Supports staff with implementation of system workflows.
Supports record retention and management including archiving and record destruction by established vendors.
Interpret existing and proposed regulatory
Assist with the resolution to questions of a regulatory nature.
Disseminate regulatory information and updates.
Implement regulatory training plans and initiatives.
Assist with operation of the IACUC and IRB committee functions to ensure compliance with animal welfare regulations and the human subjects regulations, respectively.
Bachelor's Degree and 0 years of experience, or equivalent combination of education and experience.
Excellent knowledge of MS Word, Outlook, PowerPoint, Excel
Ability to manage multiple priorities
Ability to work well with others
Ability to listen and communicate well both verbally and in writing
Ability to work independently
Ability to lift up to 35 pounds
Attention to detail and accuracy
Ability to obtain proper security clearances as noted by contracts
For San Francisco, CA USA Job Postings Only: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Further information is available here.
RTI accepts applications to our job openings from candidates with criminal histories or conviction records in accordance with all applicable laws, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
The anticipated pay range for this role is listed below. Our pay ranges represent national averages and may vary by location as a geographic differential may be applied to some locations within the United States. RTI considers multiple factors when making an offer including, for example: established salary range, internal budget, business needs, and education and years of work experience possessed by the applicant. Further, salary is merely one element to our offer.
At RTI, we demonstrate our commitment to rewarding individual and team achievement through a total rewards package. This package includes (among other things) a competitive base salary, a generous paid time off policy, merit based annual increases, bonus opportunities and a robust recognition program. Other benefits include a competitive range of insurance plans (including health, dental, life, and short-term and long-term disability), access to a retirement savings program such as a 401(k) plan, paid parental leave for all parents, financial assistance with adoption expenses or infertility treatments, financial reimbursement for education and developmental opportunities, an employee assistance program, and numerous other offerings to support a healthy work-life balance.
Salary : $59,000 - $73,000