Top Regulatory Affairs Executive jobs in Kansas
Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Top Regulatory Affairs Executive establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (Copyright 2024 Salary.com)
Recently Added Top Regulatory Affairs Executive jobs
Manager of Regulatory Affairs
- University of Kansas Medical Center
-
Kansas City, KS
FULL_TIME
-
Department:
SOM KC Cancer Center Clinical Trials
-----
Regulatory Affairs
Position Title:
Manager of Regulatory Affairs
Job Family Group:
Professional Staff
Job Description Summary:
Responsible for directing a research, outreach or services project(s) within a department, such as clinical trials or major software application upgrades, including managing the budget. Works with staff to develop a variety of services and technical support.
Job Description:
The Manager of Regulatory Affairs is responsible for the operational management and direct supervision of regulatory staff. This position works in direct collaboration with the Regulatory Affairs Program Directors for the continued development of the regulatory office, its services, and products in accordance with the KUCC strategic plan. As required, this position will also participate in project-related work.
The University of Kansas Cancer Center is the region's only National Cancer Institute-designated cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.
Starting salary will be between the minimum and midpoint of the range listed for this position.
We offer a comprehensive benefits package: Health, dental, vision (effective day 1), employer paid life, LTD, flexible benefits plan, miscellaneous voluntary plans available, paid vacation and sick (begin accruing upon hire), paid holidays, paid discretionary day, paid bereavement leave, paid jury duty, military leave, paid parental leave, and offer generous retirement contribution. Go to: https://www.kumc.edu/human-resources/benefits.html for more information.
In addition to the above, The KUCC reimburses our staff for maintaining their Socra certification. We also pay for one professional organization membership dues.
Join our clinical trials team where you can make a difference!
Required Qualifications:
Education : Bachelor's degree in a scientific or healthcare related field or an equivalent combination of relevant post-secondary education and work experience that equals at least 4 years.
Experience: Four or more years of clinical research experience.
Skills : Research certification required such as Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP). Demonstrated knowledge and experience with pharmaceutical sponsors and contract research organizations (CROs). Demonstrated knowledge and experience with pharmaceutical sponsors and contract research organizations (CROs). Demonstrated leadership skills to properly manage project operations. Attention to detail with excellent analytical and problem-solving skills. Ability to work effectively under periodic stressful situations. Ability to manage multiple tasks and set priorities to meet deadlines. Work within a team approach and be motivated to work consistently in a fast-paced, "customer-focused" environment. Excellent organizational, managerial, and communication skills. Excellent computer skills with Microsoft Word, Excel, and Outlook applications.
Preferred Qualifications:
Skills : Professional certification in project management. Four or more years of research project management and/or management experience in an academic setting, pharmaceutical company environment, or in a regulatory agency. Extensive knowledge of FDA regulations relevant to drugs, devices, and biologics.
Job Duties Outlined:
Project Start-Up and Maintenance
Maintain direct responsibility for study submissions to the IRB and ancillary review committees. Responsible for ensuring proper processes and maintenance for compiling/collecting, distributing, and tracking regulatory documents. Maintain timeline goals and escalate delays appropriately. Collaborate with team members to ensure regulatory documents are completed and accurate. Completion and maintenance of study file documents according to requirements of the U.S. Code of Federal Regulations, ICH GCP, and U.S. FDA guidance. Interface with pharmaceutical companies and affiliates (as appropriate). Provide updates as required, and escalate as appropriate. Update protocol and study information into the Clinical Trial Management System (Velos) for team collaboration. Provide assistance to study file reviewers during monitoring visits or audits. Prepare and file all required regulatory documents.
Expert Liaison
Monitor and report on regulatory issues. Serve as expert liaison between KUCC CTO, Sponsors, IRB, and KUMC physician investigators. Act as a regulatory resource for clinical trial teams, evaluate problems and provide solutions.
Supervision/Training of Regulatory Staff
Direct daily administrative activities of the regulatory staff by establishing priorities, assigning and tracking tasks, monitoring work and timelines. Responsible to supervise regulatory staff in terms of mentoring, coaching, individual and group training. Lead regularly scheduled department staff meetings and provide training to regulatory staff, as appropriate. Promote a positive work environment that is maintained through open, professional, and timely communication.
Program Management
Oversee regulatory functions during study start-up. Continually review and ensure adequate resources are available to meet project deliverables and milestones. Participate in proposal and budget development, as needed. Proactively track and monitor trial activities and performance. Responsible for ensuring accurate study administration information (trial activity) and regulatory tracking systems in the Comprehensive Research Information System (CRIS)/Velos. Identify trial related project issues and suggest possible solutions. Manage problem resolution through expedient and corrective means.
Strategic Planning
Develop and recommend short and long-term program objectives and strategies for higher quality and more efficient implementation of regulatory processes. Monitor progress of timelines and workloads for regulatory staff and report to the Regulatory Affairs Program Directors.
Interim Monitoring, Compliance, and Audits
Be knowledgeable, stay current and act accordingly within the framework of regulatory guidelines provided by federal, state, and local regulatory agencies and ethical guidelines pertaining to the clinical research industry. Monitor the quality and compliance standards of regulatory documents, processes, and submissions. Provide information for corrective and preventative action, as needed, to regulatory staff for continual improvement.
Other duties as assigned.
Required Documents:
Cover Letter AND Resume/CV
Employee Type:
Regular
Time Type:
Full time
Rate Type:
Salary
Pay Range:
$69,000.00 - $107,000.00
Minimum
$69,000.00
Midpoint
$88,000.00
Maximum
$107,000.00
Application Instructions:
To learn more and apply online, please visit https://kumc.wd5.myworkdayjobs.com/en-US/kumc-jobs/job/Kansas-City-Metro-Area/Manager-of-Regulatory-Affairs_JR003899 or go to https://careers.kumc.edu/ and search for position number JR003899.
Applications must be submitted directly through the KU Medical Center website to be considered for this position. Any applications submitted via email or this website will NOT be reviewed or considered.
About KU Medical Center:
The University of Kansas Medical Centers mission is to educate exceptional health care professionals through a full range of undergraduate, graduate, professional, postdoctoral and continuing education programs in the schools of Medicine, Nursing and Health Professions. KU Medical Center also advances the health sciences through world-class research programs; provides compassionate and state-of-the-art patient care in an academic medical center environment; and works with communities in every Kansas county to improve the health of Kansans. Learn more at www.kumc.edu .
Benefits:
KUMC offers a range of great benefits that support employees and eligible family members. Our health insurance benefits begin on hire date and KUMC offers other exciting benefits such as paid parental leave, generous employer retirement contributions and other resources to improve health and well-being. For more information, please visit https://www.kumc.edu/human-resources/benefits.html
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Regulatory Affairs Manager
- Vornado Air, LLC.
-
Andover, KS
FULL_TIME
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Regulatory Affairs Specialist
- Vornado Air, LLC.
-
Andover, KS
FULL_TIME
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Scientific and Regulatory Affairs Professional
- Cargill
-
Wichita, KS
OTHER
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Sr. Manager Regulatory Affairs Ad/Prom
- ProPharma Group
-
Overland Park, KS
FULL_TIME
- Company DescriptionProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle f...
- 14 Days Ago
Director of Public Policy & Regulatory Affairs - Remote
- CRH
-
Overland Park, KS
FULL_TIME
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Regulatory Affairs Expert
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Regulatory Affairs Specialist
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Regulatory Affairs Expert
- Integrated Resources, Inc ( IRI )
-
St Louis, MO
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Regulatory Affairs Specialist
- ProKatchers LLC
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St Louis, MO
- Job Title: Regulatory Affairs Specialist Location: 63103, St Louis, Missouri, United States Duration: 24 Months Job Desc...
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Regulatory Affairs Officer
- Brio Group
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- Job Title: Regulatory Affairs Officer Company: Biopharma Organization Location: Hybrid, RTP Area Brio Resource Group is ...
- 4/25/2024 12:00:00 AM
Regulatory Affairs Expert
- ProKatchers
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St. Louis, MO
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Regulatory Affairs Expert
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Regulatory Affairs Specialist
- Prokatchers Llc
-
Saint Louis, MO
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About Kansas
Kansas /ˈkænzəs/ (listen) is a U.S. state in the Midwestern United States. Its capital is Topeka and its largest city is Wichita, with its most populated county being Johnson County. Kansas is bordered by Nebraska on the north; Missouri on the east; Oklahoma on the south; and Colorado on the west. Kansas is named after the Kansa Native American tribe, which inhabited the area. The tribe's name (natively kką:ze) is often said to mean "people of the (south) wind" although this was probably not the term's original meaning. For thousands of years, what is now Kansas was home to numerous and divers...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$278,859 to $456,220
Most Popular Cities in Kansas for Top Regulatory Affairs Executive Jobs
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