Coordinator, Regulatory Job Description
Coordinator, regulatory
provides thoughtful & accurate comments during document review with focus on US, international, and ICH regulatory guidelines.
Coordinator, Regulatory Duties & Responsibilities
To write an effective coordinator, regulatory job description, begin by listing detailed duties, responsibilities and expectations. We have included coordinator, regulatory job description templates that you can modify and use.
Sample responsibilities for this position include:
Maintenance and coordination of financing calendar associated with the issuance of municipal bonds and the preparation of regulatory check list memorandums and its various components to document compliance with regulatory requirements associated with the offering of municipal bonds
Translate regulations including research and locate information on regulatory requirements and products
Monitor lending related activities to ensure compliance with established policies and procedures, and state and/or regulatory requirements
Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements.Search Jobs US
Compiling lobbyist spreadsheets, tracking Independent Registered Municipal Advisors that the team interacts with
Interacting with banking staff located primarily in New York City and also in regional offices throughout the country
Review raw material and ingredient compositions for regulatory conformity based on industry guidelines / international restrictions
Maintain regulatory standards and protocols to ensure compliance with various international regulations
Prepare and submit regulatory notifications and registrations as required by US/L’Oreal/international standards to ensure compliance and timely approval for market release of new and existing products
Create and review INCI’s for artwork
Coordinator, Regulatory Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Coordinator, Regulatory
List any licenses or certifications required by the position: CITI, ACRP, CPHQ, CJCP, PMP, CPIA, GMP, RAPS, AALAS, BA
Education for Coordinator, Regulatory
Typically a job would require a certain level of education.
Employers hiring for the coordinator, regulatory job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Collage Degree in Education, Science, Communication, Health, Business, Associates, Healthcare, Human Relations, Nursing, Medical
Skills for Coordinator, Regulatory
Desired skills for coordinator, regulatory include:
Order to provide effective consulting advice
Adobe Acrobat
Budget creation and management
Clinical Research and regulatory forms
Regulatory requirements
Biological
Chemical
Excel
ICH guidelines and FDA
International trade matters
Desired experience for coordinator, regulatory includes:
Implement processes to ensure effective documentation control and management of international product dossiers and compliance files
Identify areas of process improvement and assist to propose new solutions designed to increase value and improve performance
Establish and foster interaction with regional colleagues with regard to matters associated with safety,regulatory and claims
Aptitude to analyze and interpret related cosmetic regulations and compliance standards
Knowledgeable in current policies, practices, trends, technology, and information affecting the over the counter industry
Works well with others to support business initiatives
Coordinator, Regulatory Examples
1
Coordinator, Regulatory Job Description
Job Description Example
Our company is hiring for a coordinator, regulatory. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for coordinator, regulatory
- Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies
- Answers plant questions related to item master data or product regulatory requirements and provide guidance and training to plants on departmental procedures
- Liase internally with Account team to align on schedules, submission dates
- Assists department administrator and Manager of Research Administration in maintaining department’s research compliance program by ensuring adherence to all University policies and procedures, federal, state, and other funding agency rules and regulations
- Facilitate the regulatory dossier submissions to HA (IND, CTA, BLA, NDA, etc) utilizing internal and external resources
- HMDA Reporting remediation
- Prepares and Issues Adverse Action Notices
- Creates and monitors reports to track quality of loan file for activities related to Opening, Processing, Underwriting and Closing
- Support the Compliance Department with regard to the conducting scheduled monitoring and testing, tracking industry compliance updates
- Participates in ongoing compliance training
Qualifications for coordinator, regulatory
- Bachelor's degree in health science or related degree
- Proficient in accessing and downloading information from web sites
- Ability to work well with others in various departments under pressure, and meet time deadlines
- Assure staff and investigator training on and adherence to Department of Radiology clinical trials SOPs
- Collaborate with clinical staff in the hospital to ensure tests and procedures are scheduled and performed correctly
- AA/AS
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Coordinator, Regulatory Job Description
Job Description Example
Our growing company is hiring for a coordinator, regulatory. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for coordinator, regulatory
- Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC
- Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study
- Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date
- Attends weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments
- May be required to develop clinical trial budgets
- May provide training and education of other personnel
- May participate in centralized activities of the department or institution
- May plan and coordinate strategies to improve existing standard operating procedures related to regulatory affairs
- Educates Specialty Pharmacy caregivers and performs continual quality assurance monitoring
- Prepares agendas and minutes for group and department meetings
Qualifications for coordinator, regulatory
- Experience interacting, advising, and communicating effectively both orally and in writing
- Experience developing information documents and making presentations to groups and individuals
- Mobility to move in and around plant and office facilities and around job sites out-of-doors
- Ability to operate tools and equipment as required
- Communicate and exchange verbal information and instructions
- Bachelor's degree in an applicable field or equivalent applicable work experience
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Coordinator, Regulatory Job Description
Job Description Example
Our innovative and growing company is looking for a coordinator, regulatory. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for coordinator, regulatory
- Periodically audits plant regulatory programs and contacts plant staff for review and remediation of discrepancies in ERP systems and other plant programs related to product compliance issues
- Reviews test data for accuracy and completeness and processes test results from the laboratory
- Maintains various files including compliance data, specification request / change data, reports, records, and other material specific to the department
- Develops schedules for plant inputs for item master updates or regulatory testing
- Coordinates changes to ERP or regulatory compliance data with other departments as necessary
- Maintains established procedure documents and recommends revisions or new procedures as appropriate
- Updates and/or writes and distributes specific communication pieces as directed
- Maintains filing systems for all data according to department procedures
- Collects information and prepares various department reports
- Coordinates and/or conducts special projects as assigned
Qualifications for coordinator, regulatory
- Some knowledge of regulatory affairs requirements for distributors at the state and federal levels (i.e., BOP and FDA) would be beneficial
- 3 years of experience in clinical research or a related field
- Experience working with sponsors, FDA and consortiums preferred
- Ability to work with a variety of faculty and staff outside agencies
- Two years experience with inpatient and/or retail/outpatient pharmacy service areas
- Working knowledge of MS Office software and computer operations
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Coordinator, Regulatory Job Description
Job Description Example
Our innovative and growing company is looking for a coordinator, regulatory. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for coordinator, regulatory
- Acts as a liaison between the Principal Investigators (PI) and internal and external parties necessary for protocol development and activation
- Prepares and processes applications for committee review and approval of new clinical research trials, protocol revisions, annual renewals, and final study reports
- Submits applications to both internal and external regulatory authorities while adhering to deadlines
- Composes and amends regulatory documents such as informed consent forms and study protocols in accordance with institutional IRB and FDA guidelines
- Obtains and maintains required regulatory documentation and study specific regulatory binders for all studies
- Prepares serious adverse events and IND safety reports for IRB and FDA submissions
- Coordinates distribution of applications to investigators, pharmacy, division, and department for appropriate sign-off
- Assists in the regulatory coordination of investigator-initiated clinical trials
- Provide regulatory case project management over the preparation of the case application, minimum filing requirements, expert witness testimony, supporting exhibits, the discovery process, and overall timing until the case is complete
- Manage, coordinate, and oversee other regulatory projects and processes
Qualifications for coordinator, regulatory
- CIP,CIM, CCRC ,CCRP required or must be obtained within 2 years of employment
- Project tracking, database management and file management experience strongly preferred
- Two years in a regulatory affairs or compliance role with hands on experience preparing and submitting regulatory documentation
- A bachelor’s degree in a health care related field or equivalent combination of education and experience
- Knowledge of accreditation and other regulatory standards
- Knowledge of Lean Healthcare principles and quality improvement tools
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Coordinator, Regulatory Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of coordinator, regulatory. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for coordinator, regulatory
- Exercise good judgment and discretion when communication with internal and external constituencies
- Uphold the standards of confidentiality as required by law and company policy
- Provide day-to-day departmental support activities to Regulatory Submissions Coordinators
- Collect, review, organize, and assemble regulatory start-up submissions
- Have the ambition to achieve goals/objectives and the discipline, organization and perseverance to deliver outstanding customer service
- Focus on delivering what’s required
- Establish SMART objectives for self and others
- Be enthusiastic and works with energy to achieve company standards and goals
- Monitor progress of objectives and take action to ensure delivery to agreed timescales
- Plan, organize and prioritize workload effectively
Qualifications for coordinator, regulatory
- Demonstrated ability to influence outcomes and deliverables, even in the absence of formal authority
- Experience with PowerPoint, Access, and MS Project or project management software, preferred
- Proficient with computer systems (MS Office necessary
- Acts as liaison between research staff (PI, faculty, nurses, technicians, ), and internal/external regulatory and oversight groups (NU’s IRB, sponsors (NIH, industry), government agencies (FDA), ) to resolve issues and problems, negotiate compromises, and offer alternatives and recommendations to facilitate and expedite research while ensuring compliance
- Determines compliance required documentation and drafts necessary items such as protocols, informed consent, Ensures accuracy of IRB approval letters with respect to sponsor information and NIH grant identifiers
- Researches new and updated rules and regulations associated with clinical research studies and trials involving human subjects