JOB POST: Regulatory Affairs Specialist at Imaging Endpoints, Hyderabad: Apply Today

Imaging Endpoints (IE) invites applications from interested and eligible candidates for the post of Regulatory Affairs Specialist.

About Imaging Endpoints

They are the world’s largest oncology-focused imaging CRO (iCRO); they specialize in developing and deploying optimal imaging in early to late-stage clinical trials and supporting regulatory submissions. Imaging Endpoints is based in Scottsdale, Arizona where they serve the West Coast and the Midwest of the United States as well as the Pacific Rim.

Education & Experience

  • Bachelor’s degree a pharmaceutical sciences or other related scientific discipline.
  • Minimum five (5) years of experience in a regulated industry with at least three (3) years of experience in pharmaceuticals and/or medical device.
  • QMS experience.
  • Imaging Core Lab and/or Contract Research Organization experience preferred.
  • Knowledge and understanding of 21CFR Part 211, 21CFR Part 312, IS 9001, and Good Clinical Practices (ICH E6 GCP), Good Documentation Practices (GDP) and Good Manufacturing Practices (GMPs) preferred.
  • Proficiency in MS Office and internet applications
  • Past experience with electronic document management systems in life sciences industry.

Job Role

  • Provide regulatory assistance within the regulations of investigational products and quality standards, including but not limited to 21 CFR Part 312, 314, 50, 54, 211, ICH E6(R2), Clinical Trials Imaging Endpoints Process Standards, GDPR, international GCP regulations, HIPAA, Risk Management, BIMO, and ISO 9001/13485.
  • Interface with Scientific Affairs, Operations, and Clinical departments on regulatory issues providing expertise and support as required.
  • Develop and manage IE’s regulatory intelligence program.
  • Assess current regulatory GCP trends in the industry and developing a process to identify, control, and maintain documents of external origin.
  • Perform regulatory review and approval of scientific, clinical, QMS, and regulatory documents.
  • Project specific (e.g., Image Review Charters, RPMPs, Interim and Final Reports).
  • Criteria assessments.
  • Deviations and CAPAs with regulatory impact.
  • Regulatory, clinical, and scientific standard operating procedures (SOPs).
  • Business proposals, RFIs, and other client facing documents.
  • Work with SA and DM to provide regulatory guidance related to data or reporting used to support product submissions or communications to regulatory agencies.
  • Interface with Compliance and Regulatory Affairs senior management to implement regulatory strategies and plans to facilitate continuous improvement of the QMS regarding regulatory affairs initiatives.
  • Provide regulatory support for internal audits, sponsor audits, and regulatory inspections.
  • Interface with vendors that provide Regulatory support and Compliance related services.
  • Interface with Sponsors/CROs with respect to regulatory strategy and study requirements.
  • Provide Regulatory training to IE personnel related to current industry practices and interpretation of FDA guidance, regulations, and standards.
  • Assist the Chief Compliance and Regulatory Affairs Officer in establishing and reporting quality and regulatory metrics.
  • Ensure proper control, retention, and archival of QMS documents per regulatory requirements.
  • Develop SOPs and controls related to regulatory requirements as needed.
  • Assist in establishing, implementing, and maintaining procedures and controls to develop an effective, efficient, and compliant document management program.
  • Responsible for the quality of documentation created and approved to support GxP activities for IE and sponsor related projects.
  • Perform other duties as assigned by Compliance and Regulatory Affairs senior management.
  • Act in a supporting role to the RA Director when delegated duties.

Skills

  • Work precisely and in compliance with all procedures, rules and regulations.
  • Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.
  • Excellent interpersonal, organizational and communication skills, including oral and written.
  • Self-motivated and able to grasp new concepts and learn quickly.
  • Ability to motivate others and facilitate a positive work environment.
  • Ability to manage projects and deliverables with a high level of accuracy and completeness.
  • Ability to work independently with minimal supervision.
  • Excellent hands-on computer skills with thorough knowledge of Microsoft Office to include Word, Excel and Power Point.

Click here to apply for the post of Regulatory Affairs Specialist at Imaging Endpoints

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