Regulatory Affairs Expert - Remote
YO AI Labs
Austin, TX
- Remote job
Job Description
Job Description
Job Title: Regulatory Affairs Specialist
Location: Remote
Job Type: Contract Job Description
We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating regulatory documentation. The role involves assessing clinical documents, ensuring compliance with regulatory guidelines, identifying inconsistencies, and providing clear, evidence-based feedback to improve AI-generated regulatory content.
Key ResponsibilitiesReview and evaluate clinical and regulatory documentation.
Assess regulatory submissions and responses for accuracy and compliance.
Ensure adherence to ICH guidelines and CTD/eCTD requirements.
Identify regulatory risks, inconsistencies, and unsupported claims.
Prepare structured, guideline-based written feedback.
5+ years of Regulatory Affairs experience in the pharmaceutical, biotech, or CRO industry.
Experience with clinical submissions , regulatory documentation, and health authority interactions.
Strong knowledge of ICH guidelines and CTD/eCTD structure.
Excellent analytical, critical thinking, and written communication skills.
Degree in Life Sciences, Pharmacy, Medicine, or a related field .
Vacancy posted 27 days ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs Expert - Remote in Austin, TX vacancy
- UAE Legal Expert Commercial Fraud / Corporate Compliance / Regulatory Matters Location: UAE Local Candidates Only Work Arrangement: Remote Engagement: Contract Position Overview... ...Compliance Regulatory Affairs / Regulatory Matters...Remote workContract workLocal area
Inceptra Solutions LLC
Remote1 day ago - ...Job Description Job Description Job Title: Regulatory Affairs Specialist Location: Remote Job Type: Contract Job Description We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating...Remote workContract work
YO AI Labs
Boston, MA8 days ago - ...industry's leading scientists, medical and technical experts, and human capital and organizational... ...you and contact us. Senior Small Molecule Regulatory Affairs & Compliance Subject Matter Expert Location: Remote (U.S.-based) with approximately 20–25% travel...Remote workFor contractors
Tunnell Government Services
Washington DC2 days ago - ...external and internal regulations, procedures and guidelines.You’ll be based in our Raleigh office with the flexibility of hybrid remote work. Occasional global travel (up to 10%) may be required to support project needs. If you’re passionate about electrical engineering...Remote workFull timeWork at office
- ...The Design & Sales Expert sells products by providing in-home consultations to customers using design tools and services to plan and design... ...position is an individual contributor This position is fully remote based out of Naples/Ft. Meyers Florida A Day in the Life of...Remote workLocal areaWork from homeShift work
Crate&Barrel
United States5 days ago - DaMar Staffing is seeking a full-time Remote Certified Coder to assign diagnostic and procedure codes to medical records, ensuring coding accuracy and regulatory compliance. The role requires CPC or COC certification, 1 year ICD coding experience, and a high school diploma...Remote jobFull timeWork from home
- A leading global Contract Research Organization is seeking a Drug Safety Officer to manage drug safety issues in compliance with regulations. The role involves overseeing clinical trials and ensuring safety protocols are followed. Candidates should have at least 5 years...Remote workContract work
TFS HealthScience
Vermont4 days ago $75 - $105 per hour
...About the job Remote | Compliance & Risk Expert - $75-$105/hour We are sharing a specialised remote opportunity for professionals experienced... ...compliance, risk assessment, internal controls, audit, regulatory frameworks, and structured risk review. This...Remote workHourly payWeekly payContract workFor contractorsFlexible hours24-MAG LLC
United States2 days ago- ...Title: Senior Subject Matter Expert *Local to DMV area Description: • Design and implement hybrid and cloud-native architectures... ...Entra ID) and support multi-factor authentication for secure remote access to internal systems and applications. • Implement secure...Remote workWork experience placementWork at officeLocal area
3B Staffing LLC
Laurel, MD1 day ago - ...supports a smooth revenue cycle flow. The position emphasizes collaboration with clinical liaisons and leadership to identify charging opportunities and maintain high standards of service. Remote work option may apply depending on location. #J-18808-Ljbffr DaMar StaffingRemote job
- SSM Health is hiring a remote Coder II Professional to accurately code and abstract medical records for billing and reimbursement. You will review patient information, assign CPT-4 and ICD-10 codes, and ensure compliance with coding guidelines. This remote position supports...Remote job
- Infinx is seeking a ProFee Coder with Edits & Rejections expertise to support the RW - Onshore department in remote settings. You will code professional fee services, review edits and denials, and ensure coding compliance to optimize revenue capture. The role requires...Remote job
- Aldridge Pite, LLP seeks a dedicated litigation professional for remote work from home. The ideal candidate will have at least two years of litigation experience, particularly in foreclosure. Responsibilities include preparing Motions for Summary Judgment, communicating...Remote jobWork from homeFlexible hours
- ...changes and contribute to process improvements. The role requires substantial SBA and loan operations experience, with strong organizational and communication skills. Remote work is possible with onsite requirements depending on location. #J-18808-Ljbffr Northwest BankRemote job
- Dane Street, LLC is seeking a Trucking Safety & Compliance Expert (Independent Contractor) to provide expert analysis in legal claims related to trucking safety. Responsibilities include reviewing driver qualification files, accident reports, and authoring expert reports...Remote jobFor contractors
- ICF seeks an APD Expert to guide development, review, approval, and management of Advance Planning Documents and related project documentation with federal alignment. You will collaborate with the Children’s Bureau, States, and Tribes to advance technology modernization...Remote jobWork at office
- ...A progressive consulting company seeks a Bilingual Portuguese Government/Public Policy Expert to translate and adapt government frameworks for AI training. This remote, hourly contract role requires native-level Brazilian Portuguese and strong English proficiency. Responsibilities...Remote workHourly payContract work10 hours per weekFlexible hours
Crossing Hurdles
United States2 days ago - A leading regulatory consulting firm is seeking a Market Conduct Examiner to conduct compliance reviews for major insurance companies. Responsibilities include performing examinations, drafting reports, and analyzing insurance practices to ensure adherence to legal standards...Remote jobWork from home
$110k - $140k
Explosives Safety Subject Matter Expert — Explosive SME Location: Arlington, Virginia with nationwide travel Employment: Full-time; approximately... ...Department of Defense requirements. Responsibilities ~Support remote and onsite explosives and range-safety assessments. ~Evaluate...Remote workFull timeContract workSummit Technologies, Inc.
Arlington, VA10 days ago- YO AI Labs seeks a Pharmacovigilance Expert contractor to contribute drug safety expertise to an AI-driven healthcare project. You will review DSURs/PSURs, safety data, and regulatory content to ensure accuracy and compliance, with no AI domain experience required beyond...Remote jobFor contractors
- Job Description Role Title: Logistics & Supply Chain Management Expert Role Type: Contract Location: Remote Scope Of Work Review, analyze, and provide input on logistics documents such as packing lists, bills of lading, and inventory registers for authenticity, accuracy...Remote jobContract work
- ...Trucking Safety & Compliance Expert (Independent Contractor) Location: Remote / Nationwide Engagement Type: Independent Contractor (1099) Dane Street... ...depositions or trial settings as a disclosed expert. Regulatory Mastery: Expert-level knowledge of FMCSR, CDL...Remote workHourly payPrice workFor contractors
$50 - $90 per hour
...advanced detection frameworks and train AI systems to recognize, assess, and respond to realistic fraud and compliance risks. This remote contractor opportunity centers on turning practical knowledge into high-quality scenarios, evaluation criteria, guidance, and feedback...Remote workHourly payFor contractorsSaidGig
United Statesa month ago$125k - $200k
...seeking an Affordable Housing Compliance Expert to join a product and affordable compliance team based in New York, NY, with remote work considered for the right profile. This... ...near-term Ability to communicate complex regulatory requirements clearly to technical teams without...Remote workRelocation packageFlexible hours- ...Federal customers. We are hiring a Senior ATO/A&A Subject Matter Expert to support an enterprise-level program within a federal... ...transportation, personal or Government vehicle to drive to local and/or remote office locations.Additional RequirementsOther duties as assignedESM...Remote workFor contractorsWork at officeLocal areaImmediate start
ESM
Washington DC10 days ago $90 - $100 per hour
...Environmental Law) Type Contract Compensation $90-$100/hour Location Remote Role Responsibilities Construct scenarios spanning civil... ...systems used by legal aid organizations and nonprofits, and regulatory filing systems (e.g., EPA dockets). Apply public interest law...Remote workContract workSummer workWork at office- ...and ensure compliance with federal cybersecurity mandates. Ideal candidates will possess extensive experience in security architecture and risk management, with strong Azure skills. This opportunity offers competitive compensation and remote work options. #J-18808-LjbffrRemote work
Jobgether
United States1 day ago $150k - $190k
...of Our Nation Blake Willson Group (BWG) unites deep domain experts with technologists who leverage industry-leading financial management... ...with speed. Job Location: This position is primarily remote with occasional onsite travel to Washington, DC, approximately...Remote workFor contractorsLocal areaBlake Willson Group
Washington DC2 days ago$126k
...and risk in all that we do and achieve regulatory outcomes that support the business’ needs... ...(EII) Team as an Incident Investigator, Expert. The EII team is responsible for reporting... ...position is hybrid, working from your remote office and assigned office based on business...Remote workWork experience placementWork at officeFlexible hoursPG&E Corporation
Modesto, CA5 days ago- ...Job Title This is a remote position. Job Description From... ...expertise in Quality, Regulatory Compliance and Manufacturing... ...safety. Responsibilities: Provide expert consultation and support in bioequivalence... ...teams, including regulatory affairs, clinical development, and...Remote workContract work
Pharmavise
United States1 day ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Expert - Remote. Be the first to apply!
Related searches
- subject matter expert Austin, TX
- fulfillment expert Austin, TX
- guest service support expert Austin, TX
- technology expert Austin, TX
- regulatory coordinator Austin, TX
- regulatory contract Austin, TX
- regulatory scientist Austin, TX
- regulatory engineer Austin, TX
- regulatory executive Austin, TX
- food regulatory Austin, TX