Medasource | Senior Regulatory Affairs Consultant | houston, tx

2 weeks ago

houston, United States Medasource Full time

Sr. Regulatory Affairs Specialist

3+ Month Contract

ASAP

100% Remote, but prefers local to Houston, TX


Summary:

The Senior Regulatory Affairs Specialist is responsible for leading and coordinating entire regulatory submission filings of both investigational and marketed products utilized at our Client for patient care and research activities. This includes developing regulatory strategy for individual investigational products that are in development and communication of those plans to cross functional team members throughout the organization. This is responsible for end-to-end compiling of information needed to support both investigational and marketing applications to Food and Drug Administration (FDA) and other relevant Health Authorities. Responsible in initial filings of application and maintaining compliance reporting and maintaining regulatory approvals from applicable Health Authorities. This position will interface with the FDA and other applicable Health Authorities. Performs administrative duties required for direct supervision of Regulatory Affairs personnel and support staff.


EDUCATION REQUIREMENTS

  • Bachelor's degree in life sciences or related field
  • Master’s degree preferred


EXPERIENCE REQUIREMENTS

  • Six years of Regulatory Affairs experience within an FDA regulated industry, preferably devices, diagnostics, or pharmaceuticals and/or within an academic medical center setting that routinely requires investigational or marketing submissions to FDA or similar Health Authorities.
  • Experience of successful submission of applications to Health Authority including Investigational Drug, Device (IND/IDE) compassionate use, pre-submission requests, market applications
  • Experience filing with IND/IDE, from academic setting with investigator qualities such as filing investigator access use


CERTIFICATIONS, LICENSES AND REGISTRATIONS REQUIRED

  • Regulatory Affairs Certification (RAC) preferred
  • CCRC (Certified Clinical Research Coordinator) preferred
  • CCRA (Certified Clinical Research Associate) or ACRP-CP (Association of Research Professionals-Certified Professional) preferred


KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

  • Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
  • Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security.
  • Ability to effectively communicate with patients, physicians, family members and coworkers in a manner consistent with a customer service focus and application of positive language principles.
  • Demonstrated knowledge and applied expertise in IND/IDE processes.
  • Skilled at managing multiple projects with conflicting priorities.
  • Excellent communication and interpersonal skills.
  • Proficient in MS Office products (Word, Excel, PowerPoint, Outlook, Project).
  • Working knowledge of US regulations and guidance including but not limited to FDA 21 Code of Federal Regulations.

  • Medasource | Senior Regulatory Affairs Consultant | houston, tx

    2 weeks ago

    houston, United States Medasource Full time

    Sr. Regulatory Affairs Specialist3+ Month ContractASAP100% Remote, but prefers local to Houston, TXSummary:The Senior Regulatory Affairs Specialist is responsible for leading and coordinating entire regulatory submission filings of both investigational and marketed products utilized at our Client for patient care and research activities. This includes...

  • Senior Regulatory Affairs Expert

    3 days ago

    Houston, Texas, United States Medasource Full time

    About the Role:We are seeking a highly experienced Regulatory Affairs Consultant to join our team at Medasource. As a Senior Regulatory Affairs Expert, you will play a critical role in ensuring compliance with FDA regulations and guidelines.Responsibilities:Develop and execute regulatory strategies for investigational and marketed productsCompile and submit...

  • Senior Regulatory Affairs Consultant

    2 weeks ago

    Houston, United States Medasource Full time

    Sr. Regulatory Affairs Specialist3+ Month ContractASAP100% Remote, but prefers local to Houston, TXSummary:The Senior Regulatory Affairs Specialist is responsible for leading and coordinating entire regulatory submission filings of both investigational and marketed products utilized at our Client for patient care and research activities. This includes...

  • Senior Regulatory Affairs Consultant

    2 weeks ago

    Houston, United States Medasource Full time

    Sr. Regulatory Affairs Specialist3+ Month ContractASAP100% Remote, but prefers local to Houston, TXSummary:The Senior Regulatory Affairs Specialist is responsible for leading and coordinating entire regulatory submission filings of both investigational and marketed products utilized at our Client for patient care and research activities. This includes...

  • ProNxt Consulting | Senior Technical Program Manager | houston, tx

    2 weeks ago

    houston, United States ProNxt Consulting Full time

    Job descriptionAbout us: ProNxt Consulting specializes in providing agile, tailored staffing and consulting solutions designed for startups and small to medium-sized businesses. Our mission is to connect you with top-tier talent and offer strategic guidance that aligns with your unique goals. With expertise in identifying and sourcing niche skills across...

  • Senior Regulatory Compliance Specialist

    2 days ago

    Houston, United States Houston Methodist Full time

    At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific regulatory processes such as local IRB submissions or external IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy and...

  • Regulatory Consultant

    1 month ago

    houston, United States Airswift Full time

    Airswift has been tasked by one of our major Oil & Gas clients to seek a Regulatory Consultant to work on an initial 12-month contract in Houston, TX – with a high possibility for an extension!The Regulatory Consultant will be responsible for advising clients or internal teams on regulatory requirements related to the industry they operate in. This...

  • Regulatory Consultant

    2 months ago

    Houston, United States Airswift Full time

    Airswift has been tasked by one of our major Oil & Gas clients to seek a Regulatory Consultant to work on an initial 12-month contract in Houston, TX – with a high possibility for an extension!The Regulatory Consultant will be responsible for advising clients or internal teams on regulatory requirements related to the industry they operate in. This...

  • Regulatory Consultant

    2 months ago

    houston, United States Airswift Full time

    Airswift has been tasked by one of our major Oil & Gas clients to seek a Regulatory Consultant to work on an initial 12-month contract in Houston, TX – with a high possibility for an extension!The Regulatory Consultant will be responsible for advising clients or internal teams on regulatory requirements related to the industry they operate in. This...

  • Regulatory Consultant

    4 weeks ago

    Houston, United States Airswift Full time

    Airswift has been tasked by one of our major Oil & Gas clients to seek a Regulatory Consultant to work on an initial 12-month contract in Houston, TX – with a high possibility for an extension!The Regulatory Consultant will be responsible for advising clients or internal teams on regulatory requirements related to the industry they operate in. This...

  • Senior Regulatory Compliance Specialist

    1 week ago

    Houston, United States Houston Methodist Full time

    Overview At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific regulatory processes such as local IRB submissions or external IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy...

  • Houston Psychiatrist Opportunity for a Rewarding Career

    1 week ago

    Houston, Texas, United States Department of Veteran Affairs Full time

    About the RoleAt the Department of Veteran Affairs, we are seeking an experienced and compassionate Psychiatrist to join our team in Houston, TX. This is a fantastic opportunity to make a meaningful difference in the lives of our nation's heroes.

  • Senior Regulatory Compliance Specialist

    2 months ago

    Houston, United States Houston Methodist Academic Institute Full time

    At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific regulatory processes such as local IRB submissions or external IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy and...

  • Senior Regulatory Compliance Specialist

    2 months ago

    Houston, United States Houston Methodist Academic Institute Full time

    At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific regulatory processes such as local IRB submissions or external IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy and...

  • Senior Regulatory Compliance Specialist

    1 month ago

    Houston, United States Houston Methodist Academic Institute Full time

    At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific regulatory processes such as local IRB submissions or external IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy and...

  • Senior Regulatory Compliance Specialist

    1 month ago

    Houston, United States Houston Methodist Academic Institute Full time

    At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific regulatory processes such as local IRB submissions or external IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy and...

  • talisman | Senior Air Quality Engineer | houston, tx

    5 days ago

    houston, United States talisman Full time

    Senior Air Quality EngineerLocation: Denver, CO or Houston, TXAre you ready to take on an exciting and impactful role with a leading environmental and engineering services firm? We’re seeking a Senior Air Quality Engineer who thrives on solving complex challenges, delivering innovative solutions, and making a tangible difference in the industry.As a Senior...

  • talisman | Senior Air Quality Engineer | houston, tx

    4 days ago

    houston, United States talisman Full time

    Senior Air Quality EngineerLocation: Denver, CO or Houston, TXAre you ready to take on an exciting and impactful role with a leading environmental and engineering services firm? We’re seeking a Senior Air Quality Engineer who thrives on solving complex challenges, delivering innovative solutions, and making a tangible difference in the industry.As a Senior...

  • Senior Regulatory Compliance Specialist

    2 months ago

    Houston, United States Houston Methodist Academic Institute Full time

    At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific regulatory processes such as local IRB submissions or external IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy and...

  • Strategic Director for Public Affairs and Communications

    4 days ago

    Houston, Texas, United States Locust Street Group Full time

    Role OverviewLocust Street Group is seeking an experienced Senior Director/Vice President for a senior campaign manager and strategist role in Houston, TX. This position will support the execution of integrated public affairs and communications campaigns across the country, focusing on LSG's growing business footprint in Houston and neighboring...