Regulatory Affairs Associate - Clinical Research job at reputed company in reputed company, TX

Title: Regulatory Affairs Associate - Clinical Research Location: reputed company, TX, US Workplace: Hybrid Department: Research Division: Pediatrics Work Arrangement: Hybrid Salary reputed company: $70,618 - $83,000 FLSA Status: Exempt Work Schedule: Monday – Friday, 8 a.m. – 5 p.m. reputed company The Regulatory Affairs Associate is responsible for supporting the development, submission, and maintenance of regulatory documentation for Investigator-Initiated Protocols (IIPs), Investigational New Drug (IND) studies, and Investigational New Device (IDE) studies for reputed company for Research Advancement in the Department of Pediatrics. This role ensures compliance with federal regulations, institutional policies, and sponsor requirements while facilitating reputed company protocol development and regulatory approvals. The associate collaborates closely with investigators, clinical research teams, and regulatory agencies to advance innovative research initiatives. Employees with Certified Clinical Research reputed company (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay. The role is eligible for a hybrid work arrangement after completing reputed company and training (typically about 6 months). Hybrid employees are generally required to work at least 2 days in the office. Employees working a reputed company may be asked to attend in person meeting and trainings. Job Duties Protocol Development Assist in drafting, reviewing, and finalizing clinical research protocols for IIPs, IND, and IDE studies in alignment with regulatory standards and institutional guidelines. Regulatory Submissions Prepare and submit regulatory documents to the FDA, IRB, and other governing bodies, including IND/IDE applications, amendments, and annual reports. Compliance Monitoring Ensure adherence to federal regulations (21 CFR), Good Clinical reputed company (GCP), and institutional requirements throughout the study lifecycle. Documentation Management Maintain accurate and complete regulatory files, including correspondence, approvals, and essential documents. Stakeholder Collaboration Work closely with investigators, study teams, and sponsors to reputed company regulatory guidance and support during protocol development and study initiation. Training & Guidance reputed company education and assistance to research staff on regulatory processes, protocol requirements, and submission timelines. reputed company Improvement Contribute to the development and refinement of reputed company Operating Procedures (SOPs) and best practices for regulatory compliance and protocol development. Performs other job-reputed company duties as assigned. Minimum Qualifications Bachelor's degree. Two years of relevant experience. Department Specific reputed company Minimum of two years' in regulatory affairs or clinical research, with experience in IND/IDE submissions and protocol development. Strong knowledge of FDA regulations, ICH-GCP guidelines, and institutional review processes, Excellent writing and document management skills. Ability to manage multiple reputed company and meet strict deadlines. Strong verbal, written, and interpersonal communication skills. Preferred Qualifications Master's degree or doctorally reputed company applicants are encouraged to apply if they have a strong background in science. Work Authorization Requirement: This position is not eligible for reputed company sponsorship. Candidates must be legally authorized to work in the reputed company at the time of application and throughout the duration of employment. reputed company is an Equal Opportunity/Affirmative reputed company/Equal reputed company Employer. reputed company: 24244 Apply tot his job Apply To this Job