What are the responsibilities and job description for the Regulatory Affairs Manager position at Actalent?
Our client is a rapidly expanding research organization that is looking for an experienced candidate with a research based regulatory and quality background for the position of Regulatory Manager.
Job Description
This role is responsible for the successful startup and maintenance of regulatory binders and CTMS upkeep while providing quality control to the Clinical Operations department and its processes. Will also assist in formulation and carrying out of Standard Operation Procedures and establishing a Quality Management Program. Further, this role will be responsible for the execution and oversight of quality compliance program and trainings for the organization.
Additional responsibilities:
- Abide by local, state, GCP, ICH and FDA guidelines and regulations for the maintenance of regulatory operations in clinical trials.
- Oversee the smooth-running regulatory processes at site in collaboration with team members, study investigator(s), CRO(s) and Sponsor(s).
- Ensure all required regulatory packets (documents) and IRB submissions are completed in a timely manner.
- Facilitate all required organization and study specific trainings are completed in timely manner by appropriate study staff.
- Understand prioritization of research studies and ensure all regulatory documents are in place.
- Ensure clinical staff has completed Study Initiation checklist prior to screening of first patient on the research trial
- Review SOPs with lead of Clinical Operations to ensure SOPs are put in place to oversee current and future processes.
Required Qualifications
- At least Two (2) years of recent regulatory-quality related experience in a clinic research site or similar setting.
- Relevant experience with industry sponsored clinical research trials
- Regulatory experience with Central IRB(s) and local IRB(s).
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
