What are the responsibilities and job description for the Regulatory Associate Specialist position at Actalent?
Position: Clinical Research Nurse
Location: Bethesda, MD
Therapeutic Area: Multi-Research
Qualifications: Masters in Science 2-3 years of experience with regulatory publishing, INDs and managing people/processes/reports
Professional or educational bkg in a scientific field, clinical trials, regulatory affairs or health care; familiarity with GCP and/or experience working in an FDA-regulated environment is desirable.
General knowledge of the drug/vaccine development process or clinical trials is a plus.
Experience in preparing regulatory documents, publishing regulatory submissions using electronic publishing software and proficiency in preparing documents that are compliant with electronic submission standards is a plus.
Excellent oral and written communication skills; detail-oriented and able to multi-task.
Superior organizational skills and customer service abilities.
:
Seeking Regulatory Affairs professionals who are interested in Management roles. Must hold Masters of Regulatory Affairs or someone with 3 years of experience with regulatory publishing and IND experience for the Specialist level. They are looking for 2-3 years of experience managing people/processes/reports for the Regulatory Manager role.
- Prepare, distribute and track Investigational New Drug Applications (INDs)
- Prepare FDA required IND sponsor's annual reports
- Prepare scientific and other regulatory documents for submission to the Food and Drug Administration (FDA)
- Attend scientific meetings and reviews the literature to stay current with new developments in the infections disease field (in particular, human immunodeficiency virus (HIV) and tuberculosis (TB) and therapeutic clinical research
- Preparation of investigator/pharmaceutical company meeting minutes
- Perform literature searched and extraction of information to support regulatory documents
Skills:
Regulatory, fda, regulatory submission, IND Submission, Investigational New Drug, drug safety, regulatory affairs, irb, regulatory documents, clinical trial, oncology, gcp, technical writing
Top Skills Details:
- Regulatory,fda,regulatory submission,IND Submission,Investigational New Drug,drug safety
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.
