Regulatory Affairs Director jobs in Mcallen, TX

Regulatory Affairs Director oversees regulatory matters and executes the 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 Regulatory Affairs Director 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, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Regulatory Associate
  • Pinnacle Clinical Research, LLC
  • Edinburg, TX FULL_TIME
  • Who We Are:
    Pinnacle Clinical Research (PCR)/ South Texas Research Institute (STRI) is a private, physician-led clinical research site. With a current focus on non-alcoholic fatty liver disease, fibrosis, and cirrhosis, PCR/STRI offers comprehensive liver care for clinical trial participants. We are committed to the advancement of science through our partnerships and work in drug development. To learn more about STRI, go to www.southtexasresearchinstitute.com
    The Opportunity:
    The Regulatory Associate support the clinical research trials for the site and be primarily responsible for ensuring timely and accurate submission of regulatory and IRB documents for new and ongoing studies. They will be responsible for ensuring site is adhering to all applicable regulatory regulations for the conduct of clinical research and providing regulatory guidance to clinical operations team.
    The Regulatory Associate is responsible for building and maintaining effective working relationships with internal staff/external vendors. The ideal candidate will be responsive, thoughtful, self-motivated, highly organized, and a team-player. This role reports directly to the VP of Compliance.

    Under supervision of a mentor/coach, the Regulatory Associate will be responsible for:
    Regulatory Duties:
    • Ensures that the research site follows standard operating procedures, sponsor/CRO requirements, Food and Drug Administration (FDA) regulations, ICH guidelines, and good clinical practices pertaining to the conduct of clinical pharmaceutical and device protocols
    • Maintains subject and document confidentiality, understands, and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration, good clinical practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures
    • Works under limited supervision to assure compliance with federal regulations relating to human subject research
    • Understands and applies ethical principles and multiple regulations to clinical research protocols
    • Review study protocols, informed consent documents, and other study-related documentation, to assure conformance with all applicable requirements
    • Prepares, maintains, and provides oversight to all research-related regulatory documents
    • Populates and coordinates the entire process of initial regulatory documents' submission to the IRB, sponsors, and state or federal regulatory offices as necessary
    • Compiles study information and submits initial, continuing, and final reports to the IRB and/or sponsor
    • Prepares applicable submission forms and submits updated documents, including but not limited to amendments, addendums, investigator's brochures, safety information, form FDA 1572s, and informed consent documents
    • Accurately files and maintains all necessary logs within the regulatory binder(s), assists in and manages the archival of clinical trial documents/records
    • Prepares for monitoring visits and audits
    • Manages and updates employee curriculum vitas and ensures copies of all current and applicable medical licenses are on file
    • Creates error free written documents and reports such as cover letters, notes-to-file, and memos
    • Exercises judgement within the allowable limits defined within clinical trials protocols, standard operating procedures, and under the direction from the study Investigator and supervisor
    • Interacts with internal and external personnel, including but not limited to physicians, nurses, research staff members, administration staff, industry sponsor representatives, IRBs, central laboratory/imaging personnel, and clinical trial patients and attends site initiation visits
    • Coordinates multiple projects with competing priorities and deadlines, as needed based on clinical trial protocol directives and study volume
    • Other duties as assigned
    Duties, responsibilities, and activities may change or new ones may be assigned at any time.
    Qualifications:
    • Bachelor’s Degree in scientific area of study or equivalent combination of education, training, and experience
    • Previous experience in a clinical research environment or equivalent work environment
    • 2-4 years of previous as a clinical research coordinator, clinical research assistant or regulatory associate for therapeutic clinical trials
    • Knowledge of regulations governing clinical research (CFR, GCP, HIPAA) preferred
    • Previous experience with IRB submissions and requirements
    • Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint)
    • Familiarity with clinical trial management system software, preferably Clinical Research IO
    • Basic medical knowledge, including medical terminology
    • Demonstrated competence in oral and written communication
    • Must complete CITI and GCP training certification
    • Demonstrated organizational skills and outstanding time management, including keen attention to detail
    • Possess impeccable integrity and personal and professional values that are consistent with PCR/STRI’s high standards and mission
    • Comply with the company policies, code of ethics, and guiding values at all times
    Competencies:
    • Strong analytical and problem-solving skills
    • Detail oriented with the ability to perform at a high level of accuracy
    • Proactive at identifying and addressing issues in real time
    • Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner
    • Must handle confidential matters and sensitive information with discretion and judgment
    • Ability to research regulatory issues and provide recommendations for resolution
    • Ability to handle multiple projects simultaneously
    • Ability to manage small projects and work independently
    • Ability to understand and interpret clinical research protocols and other applicable sponsor documents
    FLSA Classification: This is a non-exempt position.
    Salary and Benefits:
    South Texas Research Institute provides each of our team members with opportunities for personal and professional growth in a team-oriented working environment. We offer competitive pay, excellent benefits, and the chance to grow professionally in the healthcare industry. The salary range for this position will be commensurate with experience.
    Other benefits of the Clinical Research Data Coordinator role include:
    • Medical, Dental, and Vision Insurance
    • Life Insurance
    • Short Term Disability
    • Long Term Disability
    • Generous Paid Time Off policy
    • 401(k) Retirement Plan with company match
    South Texas Research Institute is an equal opportunity employer, committed to inclusive hiring, and dedicated to diversity in our work and staff. We strongly encourage people from all groups and communities to apply.
  • 30 Days Ago

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Graduate Research Assistant- Global Affairs
  • The University of Texas Rio Grande Valley
  • Edinburg, TX FULL_TIME
  • Location Edinburg, Texas College College of Education and P-16 Integration Department Ofc of Global Affairs Division Provost - Academic Affairs FTE Scope of Job The GRA will help Global Affairs with r...
  • 15 Days Ago

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Public Affairs Representative (Enlistment Required)
  • US Army
  • Laredo, TX FULL_TIME
  • Public Affairs Representative- US Army Enlistment Required Enlist as a soldier into the United States Army and become a certified Public Affairs Mass Communication Specialist who participates in and a...
  • Just Posted

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Director
  • F&P BRANDS
  • Mcallen, TX OTHER
  • Job Details Job Location: 48SKMC23 - Mcallen, TX Salary Range: Undisclosed DescriptionSince 1987, F&P Brands has been a franchisee of Dairy Queen and most recently became a franchisee of Schlotzsky's....
  • 12 Days Ago

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Director
  • Lynn Lee Inc
  • Hidalgo, TX FULL_TIME
  • Since 1940, Dairy Queen has been one of the world’s best known and loved brands because they have created extraordinary Fan experiences. Lynn Lee Inc. as a franchisee of forty-one Dairy Queens and gro...
  • 1 Month Ago

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Operating Director
  • Cornerstone Caregiving
  • Laredo, TX FULL_TIME
  • We are looking for someone who:Wants to leave behind the typical structured, 8-5 desk jobIs willing to bet on themselves and be financially rewarded for itEnjoys problem solving within a fast-paced en...
  • 8 Days Ago

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0 Regulatory Affairs Director jobs found in Mcallen, TX area

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Sr Software Engineer
  • Leidos
  • Alice Springs, NT
  • Description The Integrated Systems Division is seeking a Senior Software Engineer in Alice Springs, Australia to execute...
  • 7/29/2024 12:00:00 AM

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Amazon Flex Van Delivery Driver
  • Amazon Flex
  • Van Delivery Partner - Drive Your Own Van What is Amazon Flex? It's simple! Use your own van and smartphone to deliver p...
  • 4/17/2024 12:00:00 AM

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Senior Systems Administrator (Australia) - TS/SCI with Polygraph
  • General Dynamics Information Technology
  • General Dynamics Information Technology (GDIT) is seeking an IT Engineer with Microsoft Enterprise Systems Administrator...
  • 4/17/2024 12:00:00 AM

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Senior Network Administrator
  • General Dynamics Information Technology
  • GDIT has an exciting opportunity for a Sr. Network Administrator to support U.S. Army Europe as part of our EMITS progra...
  • 4/17/2024 12:00:00 AM

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Remote Licensed Talk Therapist
  • Thriveworks
  • Thriveworks is currently seeking Licensed Clinicians to provide telehealth sessions in Illinois. Thriveworks is a clinic...
  • 4/17/2024 12:00:00 AM

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Remote Licensed Talk Therapist
  • Thriveworks
  • Thriveworks is currently seeking Licensed Clinicians to provide telehealth sessions in Virginia. ***For a limited time, ...
  • 4/17/2024 12:00:00 AM

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Supply Chain Development Associate
  • Johnson Controls International
  • Apodaca, Nuevo León
  • Johnson Controls is a global diversified technology and multi industrial leader serving a wide range of customers in mor...
  • 4/17/2024 12:00:00 AM

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Lean DNA Program Manager
  • Johnson Controls International
  • Apodaca, Nuevo León
  • What you will do? Johnson Controls Global Supply Chain Center of Excellence is seeking an experienced LeanDNA Program Ma...
  • 4/14/2024 12:00:00 AM

McAllen is the largest city in Hidalgo County, Texas, United States, and the 22nd-most populous city in Texas. It is located at the southern tip of the state in the Rio Grande Valley. The city limits extend south to the Rio Grande, across from the Mexican city of Reynosa, and McAllen is about 70 mi (110 km) west of the Gulf of Mexico. As of 2017, McAllen’s population was estimated to be 142,696. It is the fifth-most populous metropolitan area in the state of Texas, and the binational Reynosa–McAllen metropolitan area counts a population of nearly 1.52 million. From its settlement in 1904, the ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$145,363 to $207,030
Mcallen, Texas area prices
were up 1.2% from a year ago

Regulatory Affairs Director in Spartanburg, SC
There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
December 13, 2019
Regulatory Affairs Director in New Brunswick, NJ
The apprenticeship programme lasts 30 months and provides a combination of Masters-level training in regulatory affairs and paid work experience.
February 12, 2020
Regulatory Affairs Director in Syracuse, NY
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
January 18, 2020