ClinDatrix is looking to hire a full time in-house Director or Manager of Regulatory Affairs and Quality Assurance. Ideal candidate should be located in Southern CA and work in the ClinDatrix office. ClinDatrix is a small service provider, CRO, located in Irvine, CA dedicated to clinical research, data management, and statistical analyses and reporting servicing the biotechnology, medical device, and pharmaceutical industries.
Responsibilities
Regulatory
- Interact closely with clients to meet their Regulatory objectives and timelines. Function will include planning of Regulatory strategies in close association with client project goals.
- Prepare, assemble, and publish all regulatory documents in paper and electronic format.
Participate in global product team meetings to provide Regulatory support and guidance, and to manage day-to-day Regulatory activities. - Provide affiliate medical personnel with Regulatory and other associated information on a regular basis and as needed on an urgent basis.
- Interpret information requests, assessing the needs of the requester and prepare customized reports to meet those needs.
- Manage documentation of the Regulatory files to maintain quality assurance consistent with FDA, Worldwide Regulatory Authorities and other appropriate regulations.
- Coordinate the global Regulatory program, ensuring that all records meet GCP, FDA, other Worldwide Regulatory Authorities and company policies.
- Develop and maintain Regulatory policies and procedures (Standard Operating Procedures, Protocol Specific Procedures, training manuals).
- Coordinate and maintain an accurate and useful database of pertinent Regulatory information. Interpret and process regulatory information for use as needed to perform function.
- Review system upgrades to ensure document and data integrity is maintained. Work closely with Information Technology to ensure any system verification is properly performed and documented.
- Continuing education: remain current with regulations and guidance documents by attending meetings, seminars, and conferences on relevant topics, and by reading the scientific literature.
- Work within a team setting to meet timelines and objectives.
- Perform other general duties as required to support other departments of the company: Information Systems and Technology, Data Management, Biostatistics, Clinical Operations, Medical Safety, and Business Development.
Quality Assurance
- Interact closely with President and CEO to meet internal Quality Assurance (QA) objectives and timelines. Function will include planning of Quality strategies in close association with company goals and needs.
- Implement QA program in accordance with company policy.
- Manage QA activities related to regulatory submissions, including document approval and release.
- Insure that other personnel involved in QA activities are qualified and trained as needed to perform this function.
- Perform and manage internal Quality Assurance audits according to the Quality Manual and relevant SOPs.
- Oversee company SOPs, in close coordination with President and CEO and Manager, Administration.
- Continuing education: Survey regulatory agencies and other materials for changes in guidelines that relate to QA activities at ClinDatrix; remain current with regulations and guidance documents by attending meetings, seminars, and conferences on relevant topics, and by reading the scientific literature.
- Strive for continual improvement of QA processes, activities, and results.
Qualifications and Requirements
- Bachelors degree or the equivalent in a scientific discipline
- Minimum of 7 years in the pharmaceutical industry, and 3-5 years of Regulatory experience
- A thorough understanding of the submission process.
- A thorough and practical understanding of FDA and EMA regulations.
- Thorough knowledge and understanding of the preparation of eCTD submissions
- Experience of at least 3 years of generating eCTD submissions
- Knowledge, use, and experience of Lorenz docuBridge for eCTD submissions
- Training and / or a thorough and practical understanding of QA principles and practices.
- Able to perform independently
- Demonstrate strong organization, communication and project management skills
To start the conversation, please write, fax or click here.