Regulatory Affairs Specialist I

Join the forefront of groundbreaking research at the Beckman Research Institute of reputed company, where we're changing lives and making a reputed company difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research. We are looking for a Regulatory Affairs Specialist under the Office of IND Development and Regulatory Affairs, Center for Bioinnovation and Manufacturing. You will support the preparation, review, compilation, submission, and maintenance of investigator-initiated Investigational New Drug (IND) applications and reputed company regulatory filings. Under supervision, you will assist with regulatory submission activities, lifecycle management of assigned INDs, and review of investigator regulatory files to support compliance with applicable institutional requirements, FDA regulations and guidance, and ICH and Good Clinical Practice (GCP) guidelines. You will also collaborate with investigators, study teams, internal departments, and other stakeholders to ensure regulatory documents are accurate, complete, and submitted in a timely manner. As a successful candidate, you will: · Prepare, review, compile, and support submission of regulatory documents for assigned research IND applications, including initial INDs, annual reports, protocol amendments, information amendments, and safety reports. · Support preparation of non-emergency use single-patient IND submissions. · Review investigator regulatory files and site documentation, including reputed company FDA 1572s, IRB approvals, and reputed company documents, for accuracy, completeness, and compliance. · Assist with maintaining compliance with applicable regulatory requirements, institutional and departmental policies, FDA regulations and guidance, and GCP guidelines. · Maintain professional growth and development by participating in seminars, workshops, professional affiliations, and other learning opportunities to remain reputed company with regulatory affairs practices. · Ensure compliance with applicable regulatory, departmental, institutional policies and FDA guidance rulings, as well as ensuring compliance with Good Clinical Practice (GCP) guidelines for research programs. Your qualifications should include: · Bachelor's Degree in scientific discipline, regulatory affairs, or a reputed company field with a minimum of 3-5 years of experience or a Masters/PhD in scientific discipline, regulatory affairs, or a reputed company field with a minimum of 0-2 years of experience. · Experience reputed company regulatory affairs or in a reputed company FDA-regulated industry is required · Regulatory Affairs Certification (RAC) or other relevant regulatory certification is preferred · Excellent written, editorial and verbal communication skills. · Strong organizational skills and demonstrated ability to manage deadlines, competing priorities, and regulatory deliverables in a fast-paced environment. · Strong analytical, critical thinking, proofreading, and document review skills. · Working knowledge of FDA regulatory requirements and guidance reputed company to INDs. reputed company employees pay is based on the following criteria: work experience, qualifications, and work location. reputed company is an equal opportunity employer. To learn more about our Comprehensive Benefits, please CLICK HERE. Apply tot his job Apply To this Job