Clinical Research Regulatory Affairs Manager
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Regulatory Affairs Manager overseeing compliance for clinical operations at Sarah Cannon Research Institute. Developing strategies to ensure FDA compliance and managing relationships with sponsors and regulators.
Responsibilities:
- Oversees all aspects of the regulatory operations for Sarah Cannon site Clinical Operations and manages the regulatory department
- Responsible for developing and implementing short- and long-term strategies for regulatory compliance
- Ensures Sarah Cannon adheres to and maintains FDA regulatory compliance
- Oversees any regulatory audit
- Works closely with department directors and/or primary investigators, industry sponsors and other outside entities
- Manages, directs, plans and schedules activities and programs for the regulatory department
- Establishes and enforces procedures for trial teams and sites compliance
- Develops and implements regulatory policies and procedures for the site Clinical Operations team
- Manages the regulatory affairs for multiple clinical trials according to FDA and GCP guidelines
- Manages relationships between industry partners and the FDA regarding regulatory compliance and auditing
Requirements:
- Bachelor's Degree
- 1+ year work experience with 5+ years' preferred in clinical research corporation and regulatory team - education may be substituted for partial experience
- Knowledge of scientific and clinical research terminology
- Knowledge of FDA and GCP guidelines
- Knowledge of organizational policies, procedures, and systems
- Advanced skills with MS Office products including Excel, Word, Outlook
- Experience meeting strict deadlines and supervising team members
Benefits:
- Total Rewards package includes comprehensive benefits to support physical, mental, and financial well-being
- Competitive compensation package determined by several factors including performance, experience and skills
Similar Jobs
Experienced Local Clinical Trial Manager – Single Sponsor
Clinical Trial Manager overseeing site management and monitoring deliverables with focus on patient safety in clinical trials. Collaborating with teams to navigate complexities in drug development and commercialization.
Clinical Trial Manager
Clinical Trial Manager at Syneos Health managing site and clinical monitoring deliverables. Ensuring compliance, patient safety, and collaborating with cross-functional teams.
Clinical Trial Manager
Clinical Trial Manager managing clinical monitoring and site deliverables for Syneos Health, a global life sciences services organization.
Clinical Trial Manager
Clinical Trial Manager responsible for clinical trial oversight and site management at Syneos Health. Collaborating with cross-functional teams to ensure compliance and deliverables are met.
Principal Clinical Research Scientist
Principal Clinical Research Scientist driving clinical evidence strategy for diagnostics at Radiometer. Leading global clinical studies and collaborating with experts across functions.
Country/Local Clinical Trial Manager – FSP
Country Study Operations Manager managing country level activities and vendor relations for clinical trials at Parexel in Germany.
Associate Clinical Trial Manager – Temporary
Associate Clinical Trial Manager responsible for day-to-day operations of Phase 3 clinical trials at 4D Molecular Therapeutics. Requires strong communication skills and teamwork.
Clinical Trial Manager I-II
Clinical Trial Manager managing clinical studies for Syneos Health in Spain. Ensuring compliance and quality throughout the study lifecycle while collaborating with global teams.
Clinical Scientist Associate Director – Late Development Obesity
Clinical Scientist Associate Director supporting late-phase clinical trials and data management at Amgen. Collaborating cross-functionally to ensure high-quality clinical data for decision-making and regulatory submission.
Clinical Scientist/Senior Clinical Scientist
Join Catalyst Clinical Research as a Clinical Scientist responsible for data assessment and clinical trials overview while working in a remote role across Europe.
Director, Clinical Research
Director of Clinical Research at Sumitomo Pharma leading planning and execution of clinical development programs. Overseeing clinical study integrity and relationships with stakeholders in various indications.
Clinical Research Program Navigator
Clinical Research Program Navigator at City of Hope guiding cancer patients and families through clinical trials. Collaborating with clinical teams to enhance patient experience and care coordination.
Clinical Scientist
Clinical Scientist supporting design and execution of real-world evidence research studies at Heart Rhythm Clinical Research Solutions. Collaborating with multidisciplinary teams to translate findings into clinical advancements.
Clinical Trial Manager
Clinical Trial Manager overseeing project deliverables in Israel for Syneos Health. Engaging with local study teams and managing site operations and stakeholder communications.
Clinical Scientist
Clinical Scientist at Catalyst Clinical Research assessing clinical data integrity and collaborating with teams. Mainly responsible for reviewing trends and findings of clinical data.
Associate Clinical Trial Manager
Associate Clinical Trial Manager supporting clinical trial activities for a leading biotechnology company. Coordinating trial operations and ensuring compliance in clinical studies.
Clinical Trial Specialist
Senior Site Management Associate ensuring compliance and data quality in clinical trials for ICON. Overseeing site management activities and mentoring junior staff for effective collaboration.
Associate Director, Clinical Scientist – Late Development, Obesity Therapeutic Area
Clinical Scientist Associate Director supporting late-phase clinical development with a focus on data quality at Amgen. Collaborating on clinical trials and ensuring high-quality clinical data results.
Clinical Scientist Director – Cardiovascular Trials
Clinical Scientist Director managing cardiovascular trials for Amgen. Supporting execution and quality delivery of global late-stage clinical studies in cardiovascular research.
Clinical Scientist, Clinical Science
Clinical Scientist responsible for administering assessments in clinical trials for mental health. Evaluating rater performance and ensuring reliable data collection in Latin America.