Regulatory Coordinator Job at Dana-Farber Cancer Institute (Boston)

Regulatory Coordinator

We are seeking a meticulous and organized Regulatory Coordinator to ensure that ...

Location

Sweden , Stockholm

Salary:

Not provided

EnglishJobs.se

Expiration Date

Until further notice

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

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

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

Spanish Speaking Regulatory Coordinator

Location

United Kingdom , Radlett

Salary:

47000.00 - 50000.00 GBP / Year

Office Angels

Expiration Date

Until further notice

Requirements

Fluent in Spanish and English (written and verbal)
Healthcare/pharmaceutical industry experience
Excellent project management and organisational skills
Strong communication and interpersonal skills for collaboration

Job Responsibility

Coordinate international product registrations and maintain compliance documentation across global markets
Manage translation workflows for IFUs, labels, and other regulatory documents
Support commercial teams with market analysis, distributor pricing updates, and tender preparation
Maintain accurate distributor agreements and respond to daily regulatory enquiries
Collaborate with marketing to localise materials and supply approved content to international partners
Work with logistics and operations teams to ensure compliant labelling, packaging, and shipment processes

What we offer

20 days + bank holidays, increases a day every year up to 25 days
Pension
Death in service up to 3x salary
Free parking on site

Fulltime

Regulatory Coordinator - Thoracic Oncology

The Regulatory Coordinators (RC) works under the direction of the Thoracic Oncol...

Location

United States , Brookline

Salary:

55530.00 - 61700.00 USD / Year

Dana-Farber Cancer Institute

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or 1 year of Dana-Farber Associate Regulatory Coordinator experience required
0-1 years of experience working in a medical or scientific research setting or comparable technology orientated business environment preferred
Fundamental knowledge of the conduct of clinical trials is preferred
Must possess excellent written and oral communication skills, maintain confidentiality of information, demonstrate good decision-making and judgment and have attention to detail and follow-through skills
Demonstrated organization and time management/prioritization skills with the ability to work independently are required
Must be proficient in the use of computers, Microsoft applications and databases
Requires experience with medical terminology
Must be able to perform day to day responsibilities duties as described above with regular and ongoing training and supervision
Attains and can demonstrate fundamental knowledge and is somewhat proficient in some or all of the following areas: DFCI, DF/HCC, ICH/GCP, FDA policy / guidance / regulation
an understanding of the IRB submission & approval process

Job Responsibility

Regulatory Compliance: Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval
Prepares and submits regulatory documentation that may include
IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA), Office of Biotechnology Activities (OBA), etc
Prepares, maintains and organizes Regulatory files for each assigned study in compliance with study sponsor requirement
Industry sponsor, DF/HCC sponsored etc
Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion
Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, DF/HCC ODQ, Industry Sponsors, and third-party auditors
Leadership and Professionalism: Maintain working knowledge of current regulations, regulatory guidance and or local policies
Assists Clinical research Manager with regulatory based training and implementation of new or revised regulation, guidance and or local policy
Present regulatory status for disease group portfolio at applicable research meetings

Fulltime

Quality Assurance Regulatory Affairs Coordinator

We are looking for a highly organised and proactive Quality Assurance Regulatory...

Location

United Kingdom , Oxford

Salary:

30000.00 - 40000.00 GBP / Year

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Proactive and able to manage multiple priorities effectively
Comfortable working in a fast-paced, regulated environment
Excellent IT skills, ability to use MS Office and pick up bespoke systems with ease

Job Responsibility

Develop and deliver QARA training and inductions on core QMS processes, procedures, and requirements
Create and maintain training materials, ensuring accurate and up-to-date training records across the business
Provide administrative support to ensure regulatory affairs (RA) activities and timelines are effectively managed
Support the development, implementation, and continuous improvement of QARA strategies and the QMS
Ensure compliance with local, national, and international regulations, monitoring regulatory changes and assessing their impact

Fulltime

Regulatory Operations Coordinator

This role is in support of Cencora's veterinary and livestock production solutio...

Location

United States

Salary:

57900.00 - 85360.00 USD / Year

Cencora

Expiration Date

Until further notice

Requirements

Bachelor's degree preferred, in healthcare or science discipline or 2 years of professional experience in a healthcare setting or pharmaceutical company
Working knowledge of FDA guidelines for post-marketing drug and medical device safety surveillance
Experience in auditing, risk management, and/or quality management
Knowledge of QMS software preferred
Excellent oral and written communication skills
Ability to effectively manage and participate in cross-functional problem-solving teams
Excellent teamwork and people skills
Ability to handle a variety of tasks simultaneously
Excellent critical thinking skills to evaluate quality problems and apply knowledge to identify appropriate solutions

Job Responsibility

Organize and support management review meetings in accordance with applicable SOPs
Work closely with subject matter experts to ensure suppliers meet quality expectations through audits, performance monitoring, and corrective actions when necessary
Negotiate and maintain quality agreements with suppliers and manufacturers for MWI’s premium brands
Respond promptly to audit inspection inquiries by providing accurate information and supporting documentation
Work with the management teams to develop follow-up action plans for addressing any identified non-compliance issues
Review and manage the documentation on adverse events and quality complaint incidents
Provide quality input for investigations and support corrective and preventive action initiatives to address root causes
Organize regular reviews Standard Operating Procedures (SOPs) and Work Instructions (WIs) with process owners to these documents align with established service standards as well as quality and regulatory requirements
Verify adherence of MWI employees to all company policies and procedures as applicable to their role and responsibilities through effective monitoring, guidance, and support during standard process implementation
Ensure that MWI License(s) as well as any other regulatory documentation is up to date

What we offer

medical
dental
vision care
comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
support for working families which may include backup dependent care
adoption assistance
infertility coverage
family building support
behavioral health solutions
paid parental leave

Fulltime

Regulatory Affairs Coordinator

The Regulatory Affairs Coordinator maintains regulatory documents related to res...

Location

United States , Bethesda

Salary:

31.25 - 36.06 USD / Hour

THE GENEVA FOUNDATION

Expiration Date

Until further notice

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

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

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

Parttime

RN Regulatory Program Coordinator

The Regulatory Program Coordinator serves as the expert resource on regulatory/a...

Location

United States , Tucson

Salary:

Not provided

Tucson Medical Center

Expiration Date

Until further notice

Requirements

Bachelor’s degree in nursing from an accredited institution
Five (5) years nursing experience in a hospital setting
Current RN licensure permitting work in the state of Arizona
Knowledge of regulatory requirements (TJC and CMS)
Knowledge of the accreditation process
Knowledge of survey preparation and required follow-up activities
Skill in written and oral communications
Skill in conducting mock regulatory surveys using the tracer methodology
Ability to interpret, prepare, and present reports to management in both written and oral formats
Ability to make presentations, design and provide training/education to staff and management

Job Responsibility

Serves as the expert resource on regulatory/accreditation and licensure standards and expectations for compliance
Designs and implements a systematic approach to ensure a high level of awareness of regulatory and accrediting agency requirements throughout the organization
Guide the development of policy and guidelines as they relate to the hospital and compliance with regulatory and accreditation guidelines
Assist in the interpretation of these policies
Provides central expertise regarding accreditation and licensure standards
Identify, plan for, communicate, monitor, and evaluate actions to comply with existing and new regulations, standards and accreditation requirements throughout the organization
Provides leadership for organizational preparation and readiness for regulatory and accreditation surveys
Implements a periodic organizational needs assessment for regulatory compliance including Intra-cycle Monitoring (ICM), using the Focused Standards Assessment (FSA) Tool required by The Joint Commission
Identify areas of vulnerability and assist area leaders in developing corrective action plans
Identify and communicate areas of success to celebrate and encourage promotion of best practices

Fulltime

Regulatory Document Control Coordinator

The Regulatory Document Control Coordinator is responsible for the organization'...

Location

United States , Sacramento, CA

Salary:

22.60 - 32.79 USD / Hour

Rentokil Initial

Expiration Date

Until further notice

Requirements

1-3 years of experience in administrative roles
Proficient in Microsoft Office Suite and Google Drive
Experience in document control
Strong written and verbal communication Skills
Technical proficiency in using electronic document systems
Attention to detail to thoroughly review documents for accuracy and consistency
Strong written and verbal communication skills
Analytical skills to identify issues and suggest improvements
High School diploma or GED required

Job Responsibility

Systematically organize product labels and SDS documents for Federal, State, and County compliance
Track document revisions, ensuring the latest version is accessible
Maintain open communication with vendors and manufacturers for requests of documents, ensuring timely delivery
Communicate the need for updated vendor and/or manufacturer contact information (Procurement Manager or Buyer)
Distribution of label and SDS documents (Web Administrator, Sales, Service Center Manager, or customers)
Link documents into the NAV system
Create an electronic document system based on service location product inventory, including user access control and document workflows
Archive inactive documents as needed electronically
Monitor compliance with document control procedures and regulatory requirements
Provide administrative and day-to-day support

What we offer

Health benefits including Medical, Dental, Vision, Disability, and Life Insurance
401(k) retirement plan with company-matching contributions
Vacation days & sick days
Company-paid holidays & floating holidays
Tuition Reimbursement benefits (for FT Colleagues)
Training and development programs available

Fulltime

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Regulatory Coordinator

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