CrawlJobs Logo

Regulatory Affairs Coordinator

genevausa.org Logo

THE GENEVA FOUNDATION

Location Icon

Location:
United States , Bethesda

Category Icon
Category:
Research and Development

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

31.25 - 36.06 USD / Hour
Save Job
Save Icon
Apply Position

Job Description:

The Regulatory Affairs Coordinator maintains regulatory documents related to research, serves as principal administration regulatory liaison for projects, develops and maintains recordkeeping systems and procedures, supervises and prepares documents which support research projects, submits and manages IRB application documents, collate appropriate trainings, and provide regulatory audit support. This research takes a deep dive into the underlying physiology of warfighters with poor sleep quality or insomnia, with a focus on quantifying the sympathetic or "fight or flight" system.

Job Responsibility:

  • Prepare and/or track Institutional Review Board (IRB) initial applications, continuing review submissions, annual reports, protocol amendments and addendums, review and edit protocols, and informed consents
  • Prepare, negotiate, coordinate and track IRB review and documentation pertinent to the use of IRB reliance/master agreements for situations when performance sites rely on an IRB at another institution
  • Prepare and file study binder, "notes to study file" and communications log/file
  • File and maintain study case report forms
  • Maintain Investigator Curriculum Vitae & license requirements and all other regulatory documents as necessary
  • Maintain and report study subject tracking
  • Promote safety and confidentiality of research participants at all times
  • Act as coordinator for weekly research meeting, including updates of current and future research, minutes and reports as needed
  • Provide administrative support to investigators and research staff as needed
  • Monitor progress of research activities and develop and maintain records of research activities
  • Ensure publicly released study information is approved by the Public Affairs Office
  • Stays up-to-date in all relevant research training
  • Maintain and update files of all applicable regulatory documentation (including protocols, approvals, amendments, modifications, etc.) as well as any communications with the sponsor or any other Federal or regulatory office (including prior approvals, change in scope, etc.)

Requirements:

  • Bachelor’s degree or equivalent work experience required
  • Regulatory and IRB submission experience required
  • 2-4 years’ experience in clinical research experience preferred
  • 2-4 years non-profit, research, or healthcare experience desired
  • Demonstrate competence in oral and written communication
  • Must be organized, strong attention to detail, and possess a positive, friendly and professional demeanor
  • Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner
  • Computer skills including at least intermediate level experience with Excel and other Microsoft Office Software
What we offer:
  • medical, dental, and vision healthcare
  • Flexible Spending Account
  • Health Savings account, with employer contribution
  • Coverage is provided for employees and family members including domestic partners
  • Short-and long-term disability
  • Employee Assistance Program
  • Life & ADD insurance
  • 403b retirement plan with generous employer match
  • flexible leave options
  • 11 paid holidays per year
  • up to 4 weeks of paid time off in a rolling year
  • Employees may qualify for PSLF as Geneva is a 501(c)(3) nonprofit organization

Additional Information:

Job Posted:
February 20, 2026

Employment Type:
Parttime
Work Type:
On-site work
Icon
THE GENEVA FOUNDATION - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Regulatory Affairs Coordinator

Regulatory Coordinator

We are seeking a meticulous and organized Regulatory Coordinator to ensure that ...
Location
Location
Sweden , Stockholm
Salary
Salary:
Not provided
englishjobs.se Logo
EnglishJobs.se
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Proven experience in regulatory affairs, clinical research, or a similar compliance-focused role
  • Solid understanding of GCP, ICH guidelines, and regulatory requirements for clinical trials
  • Strong organizational skills with the ability to manage multiple projects and deadlines
  • Excellent attention to detail and accuracy in documentation
  • Proficiency in Microsoft Office Suite and familiarity with document management systems
  • Strong communication and collaboration skills
  • Fluency in English
  • Swedish language skills are an advantage
Job Responsibility
Job Responsibility
  • Support the preparation, review, and submission of regulatory documents to authorities and ethics committees
  • Ensure all trial documentation is accurate, complete, and maintained in compliance with Good Clinical Practice (GCP), regulatory requirements, and company policies
  • Coordinate the collection, organization, and archiving of essential trial documents
  • Track regulatory submission timelines and ensure deadlines are met
  • Assist in preparing trial master files and ensuring ongoing inspection readiness
  • Collaborate with clinical operations, quality assurance, and legal teams to resolve compliance issues
  • Maintain up-to-date knowledge of relevant regulations, guidelines, and industry standards
  • Participate in audits and inspections, providing requested documentation and information
  • Monitor changes in regulatory requirements and communicate updates to relevant stakeholders
  • Provide administrative and logistical support for regulatory meetings and communications
What we offer
What we offer
  • A collaborative and quality-focused work environment
  • Opportunities for professional growth and training in regulatory affairs
  • Competitive salary and benefits package
  • The chance to contribute to clinical research projects with global impact
Read More
Arrow Right

Non-Pharma Global Regulatory Affairs Specialist

The Global Regulatory Non-Pharma Specialist manages regulatory documentation and...
Location
Location
Italy , Bologna
Salary
Salary:
Not provided
it.alfasigma.com Logo
Alfasigma
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • At least 5 years’ experience in Regulatory Affairs preferably within the food supplements, medical devices, and cosmetics sectors
  • Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred
  • Advance degree in Life Sciences, Pharmacy, Chemistry, or a related field
  • Relevant certifications in Regulatory Affairs are considered a plus
  • Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
  • Strong attention to detail, time management and organizational skills
  • Willingness to learn and ability to work effectively in a team-based environment
  • Strong communication and interpersonal skills
  • Proficiency in Microsoft Office Suite and familiarity with document management systems
  • Fluent in English, both written and spoken
Job Responsibility
Job Responsibility
  • Contributing in a cross-functional team to provide the necessary regulatory input for the development of new projects
  • Support regulatory strategies by providing impact assessments
  • Collaborate actively with the Research & Development team to integrate regulatory requirements during the design and development of assigned products
  • Prepare, organize and submit regulatory documentation for submission and maintenance of dossiers for the projects assigned
  • Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
  • Manage multiple tasks in a fast-paced environment while keeping on task and to the company’s quality standards
  • Contribute to the preparation of regulatory project updates in internal meeting and governance committee providing regulatory input and flagging risks
  • Assist colleagues with administrative tasks
  • Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
  • Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations, ensuring timely product launches
What we offer
What we offer
  • Competitive salary
  • Comprehensive benefits
  • Extensive opportunities for professional growth and development
Read More
Arrow Right

Non-Pharma Global Regulatory Affairs Manager

The Global Regulatory Sciences-Legacy Products-Non-Pharma Manager manages regula...
Location
Location
Italy , Bologna; Milano; Pomezia
Salary
Salary:
Not provided
it.alfasigma.com Logo
Alfasigma
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Proven experience in Regulatory Affairs within the pharmaceutical or life sciences industry, preferably within the food supplements, medical devices, and cosmetics sectors
  • Hands-on experience with regulatory submission processes, especially within EU and/or RoW markets or similar relevant experiences
  • Demonstrated ability to coordinate projects or deliverables with complexity and limited supervision
  • Advanced degree in Life Sciences, Pharmacy, Chemistry, or a related field
  • Good knowledge of global regulatory frameworks including EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
  • Strong organizational skills, attention to detail, and ability to manage priorities
  • Collaborative mindset and effective communication with team members and stakeholders
  • Ability to operate independently on clearly defined assignments
  • Proficiency in Microsoft Office Suite and regulatory submission/document management tools
  • Fluent in English, both written and spoken
Job Responsibility
Job Responsibility
  • Accountable for providing the necessary regulatory inputs in a cross-functional team for the development of new projects
  • Accountable for the execution and implementation of global regulatory strategies by managing day-to-day activities for assigned products
  • Manage multiple regulatory workstreams independently, including authoring, reviewing and coordinating documentation for regulatory submissions such as variations, renewals and geo-expansions
  • Provide and review regulatory assessments for change controls and product updates
  • Responsible for the preparation, review and collection of documentation for submission and maintenance of Technical File and PTD for the project assigned
  • Provide critical review of documentation supporting regulatory applications
  • Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
  • Contribute to the preparation and presentation of regulatory project updates in internal meetings and governance committees
  • Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
  • Support other relevant assignments as directed by supervisor
What we offer
What we offer
  • Competitive salary
  • Comprehensive benefits
  • Extensive opportunities for professional growth and development
Read More
Arrow Right

Regulatory Affairs Manager

The RA Manager supports Global Reg Teams in the development and execution of glo...
Location
Location
United States
Salary
Salary:
51.00 - 75.00 USD / Hour
biomarin.com Logo
BioMarin Pharmaceutical
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
  • 4+ year experience
  • Nonclinical / Clinical Regulatory Affairs experience preferred
Job Responsibility
Job Responsibility
  • Support the development of the nonclinical / clinical regulatory strategy and plan
  • Assist with selected planning, document development and meeting execution activities in preparation for HA meetings / interactions
  • Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with RNC Lead
  • Collaborate with CROs that are contracted to perform regulatory submissions/HA interactions for global clinical trials
  • With oversight by RNC lead, develop and coordinate the core nonclinical / clinical content of regulatory submissions
  • Responsible for ensuring high quality nonclinical/clinical content that adheres to regulations and guidances
  • Lead the maintenance of IND/CTAs throughout the life of the studies (e.g., annual reports)
  • Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Protocols, Annual Reports, Briefing Books, etc.) and completing regulatory documents/forms for internal review
  • Collaborate with Reg PM to create and align submission timelines
  • Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to HA
What we offer
What we offer
  • discretionary annual bonus
  • discretionary stock-based long-term incentives
  • paid time off
  • company-sponsored medical, dental, vision, and life insurance plans
Read More
Arrow Right

Head of Regulatory Affairs Americas

We're making the world of digital assets accessible and secure for everyone. Joi...
Location
Location
United States , Miami, Florida
Salary
Salary:
Not provided
https://www.ledger.com Logo
Ledger
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum 8 years experience at a financial regulatory agency or policymaking body, or covering regulatory topics in the legal, fintech, or financial services sectors
  • Prior crypto industry experience a plus
  • Knowledgeable about blockchain technology and the US and Latin America crypto-asset regulatory landscape
  • Knowledgeable about US and Latin American financial regulations, such as those applicable to crypto-asset service providers, payment services providers, E-money institutions, banks and custodians, securities and financial instrument issuers, and trading platforms
  • Specific knowledge of AML/CFT and financial sanctions law and international standards is desirable
  • Ability to quickly learn and adapt to new regulatory subject matters and jurisdictions
  • Proven relationships with key stakeholders, such as those at regulatory agencies and international bodies, legislatures, and central banks
  • Fluency in English required
  • fluency in Spanish is strongly desired
  • Exceptional communication skills, both written and verbal
Job Responsibility
Job Responsibility
  • Build and maintain subject matter expertise of the changing regulatory landscape in the areas of digital assets, financial services and capital markets
  • Advise business units and senior leadership on the development and adaptation of products, business lines and business models in light of existing or anticipated regulatory requirements
  • Define and execute strategies to proactively influence the development of favorable digital asset regulation in North and South America
  • Coordinate with the Global Head of Policy on identifying and reacting to significant public policy challenges and opportunities with respect to Ledger’s business priorities
  • Build strong relationships with other regulatory professionals in the digital asset and traditional finance ecosystems, as well as with relevant governmental authorities and multinational bodies
  • Lead the development of Ledger’s responses to regulatory proposals, solicitations and consultations
  • Lead the response of Ledger to regulatory inquiries, examinations or investigations, and contribute to crisis response teams as assigned
  • Represent Ledger’s perspective on regulatory policy through public speaking and written thought leadership
  • Assist the Global Head of Policy in managing outside consultants and membership organisations
What we offer
What we offer
  • Training: Get trained and gain experience in one of today's most exciting and growing industries
  • Equity: Employees are the foundation of our success, and we award stock options so you can share in that success as we grow
  • Medical: Comprehensive health insurance policy offering extensive medical, dental and vision care coverage
  • Well-being: Personal development, coaching & fitness with our dedicated partners
  • Vacation: 20 days of paid leave per year
  • Retirement: 401k with employer match
  • High tech: Access to high performance office equipment and gadgets, including Apple products
  • Transport: Ledger reimburses part of your preferred means of transportation
  • Discounts: Employee discount on all our products
  • Fulltime
Read More
Arrow Right

Head of Regulatory Affairs Americas

As Head of Regulatory Affairs for the Americas, you will report to the Global He...
Location
Location
United States , Washington, District of Columbia
Salary
Salary:
Not provided
https://www.ledger.com Logo
Ledger
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum 8 years experience at a financial regulatory agency or policymaking body, or covering regulatory topics in the legal, fintech, or financial services sectors. Prior crypto industry experience a plus
  • Knowledgeable about blockchain technology and the US and Latin America crypto-asset regulatory landscape
  • Knowledgeable about US and Latin American financial regulations, such as those applicable to crypto-asset service providers, payment services providers, E-money institutions, banks and custodians, securities and financial instrument issuers, and trading platforms
  • Specific knowledge of AML/CFT and financial sanctions law and international standards is desirable
  • Ability to quickly learn and adapt to new regulatory subject matters and jurisdictions
  • Proven relationships with key stakeholders, such as those at regulatory agencies and international bodies, legislatures, and central banks
  • Fluency in English required
  • fluency in Spanish is strongly desired
  • Exceptional communication skills, both written and verbal
  • comfort with public speaking
Job Responsibility
Job Responsibility
  • Build and maintain subject matter expertise of the changing regulatory landscape in the areas of digital assets, financial services and capital markets
  • Advise business units and senior leadership on the development and adaptation of products, business lines and business models in light of existing or anticipated regulatory requirements
  • Define and execute strategies to proactively influence the development of favorable digital asset regulation in North and South America
  • Coordinate with the Global Head of Policy on identifying and reacting to significant public policy challenges and opportunities with respect to Ledger’s business priorities
  • Build strong relationships with other regulatory professionals in the digital asset and traditional finance ecosystems, as well as with relevant governmental authorities and multinational bodies
  • Lead the development of Ledger’s responses to regulatory proposals, solicitations and consultations
  • Lead the response of Ledger to regulatory inquiries, examinations or investigations, and contribute to crisis response teams as assigned
  • Represent Ledger’s perspective on regulatory policy through public speaking and written thought leadership
  • Assist the Global Head of Policy in managing outside consultants and membership organisations
What we offer
What we offer
  • Training: Get trained and gain experience in one of today's most exciting and growing industries
  • Equity: Employees are the foundation of our success, and we award stock options so you can share in that success as we grow
  • Medical: Comprehensive health insurance policy offering extensive medical, dental and vision care coverage
  • Well-being: Personal development, coaching & fitness with our dedicated partners
  • Vacation: 20 days of paid leave per year
  • Retirement: 401k with employer match
  • High tech: Access to high performance office equipment and gadgets, including Apple products
  • Transport: Ledger reimburses part of your preferred means of transportation
  • Discounts: Employee discount on all our products
  • Fulltime
Read More
Arrow Right

Regulatory Specialist

At 2San, we are at the forefront of innovation in the global healthcare industry...
Location
Location
United States , Norwood
Salary
Salary:
80000.00 USD / Year
2san.com Logo
2San
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Proven regulatory affairs experience within the healthcare sector, with a focus on Class 2 and Class 3 Self-Test IVDs
  • Deep understanding of regulatory requirements and processes for the US market, including 510(k) management, FDA submissions, and compliance management
  • Experience with developing, implementing, and managing Quality Management Systems (QMS) in accordance with US and international standards, including familiarity with ISO 13485
  • Ability to develop and implement regulatory strategies that align with company objectives and product lifecycle
  • Strong analytical skills for assessing regulatory compliance, interpreting guidelines, and resolving complex issues
  • Excellent written and verbal communication skills for effective liaising with regulatory bodies, internal teams, and external partners
  • Proactive in identifying potential regulatory obstacles and developing effective solutions
  • Meticulous attention to detail with the capability to manage multiple projects and priorities simultaneously
  • Bachelor’s degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biomedical Engineering) required
  • advanced degrees or certifications in regulatory affairs or quality assurance preferred
Job Responsibility
Job Responsibility
  • Monitoring and management of new and existing 510(k) entries to ensure all product listings are current and compliant with regulatory requirements
  • Preparing and submitting FDA applications for new product approvals and amendments for existing products, ensuring all submissions are accurate and meet regulatory standards
  • Maintaining the regulatory tracker to ensure all information is current and in-line with local requirements
  • Maintaining regular contact with manufacturers for products supplier in US. Ensuring that their conformity assessment is not due to lapse and ensuring that a plan is in place for updated certification. (IVDD to IVDR)
  • Regularly reviewing and updating the Quality Management System (QMS) to ensure it aligns with both US and international standards, including ISO 13485, and addressing any gaps or non-compliances
  • Overseeing Complaints Management and Post-Market Surveillance Activities, including the collection, analysis, and reporting of customer feedback and adverse events to regulatory bodies as required. Implementing corrective actions and ensuring continuous product quality and safety monitoring in compliance with regulatory requirements
  • Collaborating with product development teams to provide regulatory guidance and support from concept through to commercialization, ensuring regulatory considerations are integrated into product lifecycle management
  • Navigating regulatory pathways to secure product approval and market entry, including strategizing for efficient and compliant product launches
  • Applying strong analytical skills to assess regulatory compliance, interpret complex regulatory guidelines, and undertake risk assessments for regulatory strategies and submissions
  • Proactively identifying potential regulatory challenges and obstacles and working collaboratively with cross-functional teams to develop and implement effective solutions
Read More
Arrow Right

Associate Director, Regulatory

This role will serve as the Regulatory Lead for our pivotal program leading to B...
Location
Location
United States , Philadelphia
Salary
Salary:
Not provided
cabalettabio.com Logo
Cabaletta Bio Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in life sciences or related field required (advanced degree preferred)
  • Minimum of 5 years of experience in regulatory affairs for biopharmaceuticals or cell therapy (preferred)
  • Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience required)
  • Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions
  • Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions
  • Excellent communication, negotiation, and leadership skills
  • Strong team orientation and passion for continuous self-development
Job Responsibility
Job Responsibility
  • Regulatory Strategy Development: Manage all regulatory aspects of Cabaletta’s lead program through pivotal clinical studies and BLA/MAA approval, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, health authority meetings, marketing applications, and labeling and promotional reviews for regulatory agencies, including FDA, Health Canada, EMA, MHRA and other countries, as applicable
  • Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development
  • Stay informed about evolving regulations and guidelines related to cell therapy and adapt strategies accordingly
  • Assess and communicate potential regulatory risks and propose mitigation plans
  • Regulatory Submissions and Compliance: Prepare and oversee the submission of regulatory documents, including INDs, CTAs, BLAs/MAAs, and other relevant submissions to regulatory agencies (e.g., FDA, EMA)
  • Ensure the quality and accuracy of regulatory submissions, adhering to timelines and requirements
  • Ensure compliance of programs and submission documentation with current regulations and guidelines governing cell therapy products
  • Regulatory Interactions: Represent the company during interactions with regulatory agencies, including meetings, teleconferences, and written communication
  • Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
  • Coordinate and prepare responses to requests for information from regulatory agencies
What we offer
What we offer
  • health and retirement, PTO, and stock option plans
Read More
Arrow Right
Jobs by Category
Art and Entertainment Jobs Banking Jobs Call Center Jobs Construction Jobs Consulting Jobs Customer Service Jobs Education Jobs Energy Jobs Finance Jobs Gastronomy Jobs Health and Beauty Jobs Hospitality and Tourism Jobs Human Resources Jobs Insurance Jobs IT - Administration Jobs IT - Software Development Jobs Legal Jobs Logistics Jobs Manufacturing Jobs Marketing, Digital Marketing, SEO, SEM Jobs Media Jobs Nursing Jobs Office Administration Jobs Pharmacy Jobs Physical Work Jobs Public Relations Jobs Public Sector Jobs Purchasing Jobs Quality Control Jobs Real Estate Jobs Research and Development Jobs Sales Jobs
Job Positions Jobs by Country
United States Jobs United Kingdom Jobs India Jobs Canada Jobs Australia Jobs Germany Jobs Ireland Jobs Poland Jobs
Company
Blog About Us Contact
Follow Us
Facebook
X (Twitter)
LinkedIn
Instagram
CrawlJobs Group
ITFlashcards AllDevBlogs
© 2026 CrawlJobs Ltd. All Rights Reserved
Terms & Conditions Privacy Policy