Regulatory Affairs Manager

6 days ago

Hyderabad, Telangana, India Imaging Endpoints Full time
Job Title: Manager, Compliance and Regulatory Affairs

Imaging Endpoints is a leading Imaging Technology and Imaging Clinical Research Organization (iCRO) passionate about connecting imaging to the cure. We are seeking a highly skilled Manager, Compliance and Regulatory Affairs to join our team.

Job Summary:

The Manager, Compliance and Regulatory Affairs will be responsible for assisting the Compliance and Regulatory Affairs Management in executing day-to-day tasks associated with managing, maintaining, and continually improving Imaging Endpoints' compliance to meet regulatory requirements.

Key Responsibilities:
  • Provide regulatory assistance within the regulations of investigational products and quality standards, specifically: 21 CFR Part 312, 314, 50, 54, 210, 211, 11, ICH E6(R2), Clinical Trials Imaging Endpoints Process Standards, GDPR, HIPAA, Risk Management, BIMO, and ISO 9001.
  • 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 by assessing current regulatory trends in the industry and developing a process to identify, control, and maintain documents of external origin.
  1. Perform regulatory review and approval of scientific, clinical, QMS, and regulatory documents.
  2. Project specific (e.g., Imaging Manuals, Image Review Charters, Interim and Final Reports)
  3. Criteria assessments
  4. Deviations, CAPAs, and other investigations with regulatory impact
  5. Regulatory, clinical, and scientific standard operating procedures (SOPs)
  6. Business proposals, RFls, 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.
Requirements:
  • Bachelor's degree in pharmaceutical sciences or other related scientific disciplines.
  • Minimum six (6) years of experience in a regulated industry with at least four (4) 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 21 CFR Part 211, 21 CFR 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.
Skills:
  • Superior attention to detail, particularly in written documentation.
  • Service-oriented approach, flexible, and proactive.
  • Self-driven, ability to get the job done with little supervision, can-do positive attitude.
  • Ability to excel in a team environment.
  • Ability to work in strict compliance with all procedures, rules, and regulations.
  • Ability to manage projects and deliverables with a high level of accuracy and completeness.
  • Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
  • Must be self-motivated and able to grasp new concepts quickly.
  • Excellent hands-on computer skills with thorough knowledge of Microsoft Office to include Word, Excel, and PowerPoint.
Imaging Endpoints' Team Characteristics:
  • Passion to connect imaging to the cure and pursue a meaningful career by improving the lives of cancer patients through imaging.
  • Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging.
  • Commitment and caring for our fellow team members, their families, and the communities IE serves.
  • Integrity and high ethical standards; we always do the right thing.
  • High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives.
  • Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day's objectives while striving to improve ourselves and IE every day.
  • Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success.
  • High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else.
Physical Requirements:

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

Travel: Estimated 10-20% travel (domestic and international)

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