... FDA submissions (initial, modifications/amendments, continuing reviews, and study closure ... This position will also mentor the entry level and mid-level staff on the team as well as cover the ...
... FDA submissions (initial, modifications/amendments, continuing reviews, and study closure ... This position will also mentor the entry level and mid-level staff on the team as well as cover the ...
... is an entry-level role focused on performing defined quality assurance tasks with remote ... Experience working in an FDA regulated environment * Experience in Federal and State Food Safety ...
... is an entry-level role focused on performing defined quality assurance tasks with remote ... Experience working in an FDA regulated environment * Experience in Federal and State Food Safety ...
... FDA submissions (initial, modifications/amendments, continuing reviews, and study closure ... This position will also mentor the entry level and mid-level staff on the team as well as cover the ...
... FDA submissions (initial, modifications/amendments, continuing reviews, and study closure ... This position will also mentor the entry level and mid-level staff on the team as well as cover the ...
How This Role Makes a Difference The Travel Clinical Research Assistant is an entry-level role that ... with FDA regulations, ICH-GCP, study protocols, and Care Access SOPs. * Site Operations ...
Quick apply
How This Role Makes a Difference The Travel Clinical Research Assistant is an entry-level role that ... with FDA regulations, ICH-GCP, study protocols, and Care Access SOPs. * Site Operations ...
... FDA submissions (initial, modifications/amendments, continuing reviews, and study closure ... This position will also mentor the entry level and mid-level staff on the team as well as cover the ...
... FDA submissions (initial, modifications/amendments, continuing reviews, and study closure ... This position will also mentor the entry level and mid-level staff on the team as well as cover the ...
Project Manager
Dallas, TX · On-site
... the entry level to around $20M at the upper range of the position.PRINCIPLE AREAS OF ... Ensure all construction activities comply with industry standards, GMP regulations, and FDA ...
Quick apply
Project Manager
Dallas, TX · On-site
... the entry level to around $20M at the upper range of the position.PRINCIPLE AREAS OF ... Ensure all construction activities comply with industry standards, GMP regulations, and FDA ...
Meet FDA requirements where applicable: • Maintain a Shutdown and Turnaround work list and ... • Support entry level technicians through coaching and mentoring. Required Skills: • Math ...
Meet FDA requirements where applicable: • Maintain a Shutdown and Turnaround work list and ... • Support entry level technicians through coaching and mentoring. Required Skills: • Math ...
... FDA submissions (initial, modifications/amendments, continuing reviews, and study closure ... This position will also mentor the entry level and mid-level staff on the team as well as cover the ...
... FDA submissions (initial, modifications/amendments, continuing reviews, and study closure ... This position will also mentor the entry level and mid-level staff on the team as well as cover the ...
Flex Shopper - Part Time
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals * May require use of ladders and other E-Commerce ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
Flex Shopper - Part Time
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals * May require use of ladders and other E-Commerce ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
Sanitation Team Member (Cleaner, Housekeeping, Custodial) - Part Time
Dallas, TX · On-site
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals. * Exposure to temperatures: 90 degrees Fahrenheit ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
Sanitation Team Member (Cleaner, Housekeeping, Custodial) - Part Time
Dallas, TX · On-site
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals. * Exposure to temperatures: 90 degrees Fahrenheit ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
Flex Shopper - Part Time
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals * May require use of ladders and other E-Commerce ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
Flex Shopper - Part Time
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals * May require use of ladders and other E-Commerce ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
Flex Shopper - Part Time
Austin, TX · On-site
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals * May require use of ladders and other E-Commerce ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
Flex Shopper - Part Time
Austin, TX · On-site
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals * May require use of ladders and other E-Commerce ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
Flex Shopper - Part Time
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals * May require use of ladders and other E-Commerce ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
Flex Shopper - Part Time
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals * May require use of ladders and other E-Commerce ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
Flex Shopper - Part Time
Highland Village, TX · On-site
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals * May require use of ladders and other E-Commerce ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
New
Flex Shopper - Part Time
Highland Village, TX · On-site
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals * May require use of ladders and other E-Commerce ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
New
HME Driver
San Antonio, TX · On-site
$15.75 - $19.50/hr
The Home Medical Equipment (HME) Delivery Driver is an entry level position whose primary ... OSHA, NFPA, FDA and DOT regulations. • The HME Delivery Driver operates vehicles in a safe ...
HME Driver
San Antonio, TX · On-site
$15.75 - $19.50/hr
The Home Medical Equipment (HME) Delivery Driver is an entry level position whose primary ... OSHA, NFPA, FDA and DOT regulations. • The HME Delivery Driver operates vehicles in a safe ...
Primate Technician I
$17.75/hr
Job Summary This is an entry-level position where you can gain experience and begin your career in ... Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits ...
Primate Technician I
$17.75/hr
Job Summary This is an entry-level position where you can gain experience and begin your career in ... Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits ...
Flex Shopper - Part Time
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals * May require use of ladders and other E-Commerce ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
Flex Shopper - Part Time
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals * May require use of ladders and other E-Commerce ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
Flex Shopper - Part Time
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals * May require use of ladders and other E-Commerce ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
Flex Shopper - Part Time
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals * May require use of ladders and other E-Commerce ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
Flex Shopper - Part Time
Highland Village, TX · On-site
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals * May require use of ladders and other E-Commerce ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
New
Flex Shopper - Part Time
Highland Village, TX · On-site
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals * May require use of ladders and other E-Commerce ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
New
Sanitation Team Member (Cleaner, Housekeeping, Custodial) - Full Time
San Antonio, TX · On-site
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals. * Exposure to temperatures: 90 degrees Fahrenheit ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
Sanitation Team Member (Cleaner, Housekeeping, Custodial) - Full Time
San Antonio, TX · On-site
$15 - $24.40/hr
Exposure to FDA approved cleaning chemicals. * Exposure to temperatures: 90 degrees Fahrenheit ... New entry level Team Members who successfully complete their first 90-days of employment and who ...
Fda Entry Level information
What are the typical responsibilities of an FDA entry level?
In an FDA Entry Level role, you may be tasked with supporting regulatory submissions, compiling and reviewing documentation, and ensuring compliance with FDA guidelines. Your responsibilities might also include data entry, assisting with laboratory tests or inspections, and helping prepare reports for internal and external stakeholders. You could work closely with scientists, regulatory affairs specialists, and quality assurance teams, which provides valuable exposure to the regulatory process and industry best practices. This hands-on experience helps you build foundational knowledge and opens the door to advancement to more specialized or senior roles over time.
What are the key skills and qualifications needed for an FDA entry level?
To thrive in an FDA Entry Level position, candidates typically need a bachelor’s degree in life sciences, pharmacy, or a related field, along with basic knowledge of regulatory processes. Familiarity with regulatory documentation, data entry systems, and software like Microsoft Office is important and some roles may require training in Good Laboratory Practice (GLP) or similar certifications. Detail orientation, analytical thinking, and strong written and verbal communication skills help candidates excel and collaborate effectively. These competencies ensure accuracy, compliance, and smooth communication in highly regulated environments.
What qualifications do I need for FDA entry level jobs?
FDA entry-level jobs typically require a bachelor's degree in a relevant field such as biology, chemistry, or health sciences. Strong attention to detail, good communication skills, and familiarity with regulatory guidelines and documentation are also important qualifications.
What is an FDA entry level?
An FDA entry-level job is a starting position within the U.S. Food and Drug Administration, typically suited for recent graduates or individuals with minimal experience in regulatory affairs, public health, or scientific research. These roles can include positions in drug evaluation, food safety, compliance, and laboratory research. Responsibilities often involve data analysis, regulatory review, inspections, and assisting senior staff with policy implementation. Entry-level professionals gain valuable experience in federal regulations, public health policies, and scientific evaluations, which can lead to career advancement within the agency.
What are the most commonly searched types of Fda jobs in Texas? The most popular types of Fda jobs in Texas are:
What are popular job titles related to Fda Entry Level jobs in Texas? For Fda Entry Level jobs in Texas, the most frequently searched job titles are:
What job categories do people searching Fda Entry Level jobs in Texas look for? The top searched job categories for Fda Entry Level jobs in Texas are:
What cities in Texas are hiring for Fda Entry Level jobs? Cities in Texas with the most Fda Entry Level job openings:
Regulatory Associate Senior, Simmons Cancer Center
Dallas, TX • On-site
Full-time
Medical, Retirement, PTO
This job post has expired today. Applications are no longer accepted.
Job description
WHY UT SOUTHWESTERN? With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report , we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career! JOB SUMMARY The purpose of this job is to work closely with investigators and research personnel on the refinement of protocol and other documents for the performance of research projects. Perform thorough protocol pre-review in advance of submission to the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC), and provide technical consultation to Principal Investigators on any regulatory, scientific, or policy issues that will affect the likelihood of IRB or IACUC approvals. The Regulatory Associate Senior will be primarily responsible for regulatory support of a specific Disease Oriented Team's (DOT) clinical trials as well as provide support and backup for other DOTs as needed. The primary role of the regulatory team is to review study protocols, draft consent forms, complete IRB and/or FDA submissions (initial, modifications/amendments, continuing reviews, and study closure), maintenance of essential regulatory documents both electronic and paper, and preparing and facilitating the DOT studies for long term storage at Iron Mountain. In addition, each regulatory team member provides ancillary services such as assisting with and maintaining the CTEP IDs for physicians as well as staff regulatory training. This position will also mentor the entry level and mid-level staff on the team as well as cover the regulatory support for the fast track program. Regulatory experience in Clinical Research strongly preferred. BENEFITS UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:
- PPO medical plan, available day one at no cost for full-time employee-only coverage
- 100% coverage for preventive healthcare-no copay
- Paid Time Off, available day one
- Retirement Programs through the Teacher Retirement System of Texas (TRS)
- Paid Parental Leave Benefit
- Wellness programs
- Tuition Reimbursement
- Public Service Loan Forgiveness (PSLF) Qualified Employer
- Learn more about these and other UTSW employee benefits!
- Education Bachelor's Degree
- Experience 3 years of related experience in review, oversight, or performance management of scientific research projects. May consider experience and education in lieu of requirements
- Education Advanced degree in health sciences field
- Experience Previous service on an IRB or IACUC a plus.
- Licenses and Certifications CERTIFIED PROFESSIONAL or Previous service on an IRB
- Collaborates closely with the IRB, IACUC, and other regulatory entities at the institution to provide optimal protocol review services for investigators.
- Prepares, submits, and revises all IRB or IACUC applications. Prepares and submits renewal and audit reports.
- Maintains working relationships with internal/external departments/agencies and other organizations associated with and/or receiving benefit from associated research projects.
- Monitors and evaluates research project quality control activities. Trains personnel on IRB, IACUC, and HIPAA compliance, and information security protocols.
- Recommends new policies and procedures for improvement of program compliance activities. Ensures compliance with applicable laws, regulations, policies, and procedures.
- Responsible for design, execution, and effectiveness of system of internal controls, which provide reasonable assurance that operations are effective and efficient.
- Reads literature and attends training and other functions as necessary to keep abreast of relevant scientific, regulatory, and technical developments related to oversight of clinical research.
- Performs other duties as assigned.