Regulatory Affairs Coordinator Job Description
Regulatory affairs coordinator
provides this support in compliance with the FDA Code of Federal Regulations(CFR), the ICH Good Clinical Practice (GCP) Guidelines, OHRP/DHHS guidelines.
Regulatory Affairs Coordinator Duties & Responsibilities
To write an effective regulatory affairs coordinator job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory affairs coordinator job description templates that you can modify and use.
Sample responsibilities for this position include:
Under supervision, develop and maintain positive relationships with U.S. FDA regulatory agency through oral and written communications regarding field action requirements
Provide monthly expiration reports to the brand teams on CRC approved materials
Generate reports that measure a variety of metrics
Manage relationships with vendors by actively participating in weekly status calls ensuring that all projects deadline lines are met
Researches regulatory guidance and emerging regulatory issues
Participate in day-to-day operations of the OTC team, including ensuring all product and project-related milestones are met
Participate in the preparation of major regulatory filings, and ensures timely completion of routine regulatory submissions required for maintenance of in-market products
Complete Health Canada Medical Device License electronic submissions
Scan documents for filing
Prepare templates for submissions (letters, submissions packages, mailing)
Regulatory Affairs Coordinator Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Affairs Coordinator
List any licenses or certifications required by the position: CITI, IRB, GMP, ACRP, RAPS, EU, SOCRA, RAC, HIPAA, CCRP
Education for Regulatory Affairs Coordinator
Typically a job would require a certain level of education.
Employers hiring for the regulatory affairs coordinator job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Healthcare, Education, Pharmacy, Chemistry, Associates, Medical, Health, Business, Biology
Skills for Regulatory Affairs Coordinator
Desired skills for regulatory affairs coordinator include:
Medical terminology
Articles
Regulatory changes through guidelines
Writings and courses
Applicable regulations governing the conduct of clinical trials
Clinical trial strategy and study design
FDA
GCP
Statistical methods and data reporting
State and local regulations
Desired experience for regulatory affairs coordinator includes:
Preferable experience in the health care environment and/or pharmaceutical industry (regulatory affairs related position preferred)
Experience working in a high volume environment handling multiple tasks
Proven experience and examples of developing and maintaining relationships across functions
Must be able to be flexible with work schedule in order to accommodate the varying volume of work and requests
Provide regulatory support for all product-specific activities related to gaining and maintaining market approval
Complete ADD templates for RA assessments
Regulatory Affairs Coordinator Examples
1
Regulatory Affairs Coordinator Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of regulatory affairs coordinator. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for regulatory affairs coordinator
- Being the primary point of contact with RA affiliates to contribute to the development and execution local registration strategy and renewals in compliance with relevant laws, regulations and organizational requirements of countries under his/her scope
- Assist the CSS EMEA Regulatory Affairs Manager - EU Strategy in monitoring developments in EU/EMEA legislation and guidelines related to the medical device industry
- Provides analytical and regulatory support to the clinical research support unit
- Supports PI s and study staff by assisting in the data collection and notification required for reporting of Adverse Events Facilitates communication with IRB related to Adverse Events Supports study monitoring, as needed and requested
- Verify and coordinate quality control of submissions proper compliance with department SOPs and Regulatory Authority guidelines
- Coordinate, obtain, legalize, compile and distribute documents needed to support global regulatory submissions
- Prepare, request and track government certifications to ensure smooth transition with registration of new products in global market
- Be responsible for handling various aspects of regulatory compliance activities for commercial health plan business
- Evaluate new state and federal regulations proposed and final state legislation in order to advance the health plan’s positions and implement compliance obligations
- Represent RCGA in internal and external implementation processes for the health plan’s new and innovative external partnerships
Qualifications for regulatory affairs coordinator
- Knowledge of chemical, microbiological and laboratory testing procedures preferred
- Knowledge of Canadian Medical Device Regulations and Health Canada Federal requirements
- Be persistent and engaged
- Be resourceful skill necessary to solve ongoing issues
- Excellent computer skills and professional demeanor required for interactions with international colleagues and health authority representatives, including a working knowledge of database management proficiency in Microsoft Word, Excel and PowerPoint
- He / She should be computer literate
2
Regulatory Affairs Coordinator Job Description
Job Description Example
Our company is looking to fill the role of regulatory affairs coordinator. 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 regulatory affairs coordinator
- Be responsible for complex regulatory reporting obligations related to cost, benefits, and network transparency
- Corrections and removals, including preparation of Monthly Status Reports and tracking Effectiveness Checks
- Coordinate submission activities and internal and external communications for U.S. field action activities
- Coordinate procedures, training and systems to ensure compliance to U.S. regulatory processes for products distributed in the U.S. with emphasis on field action compliance
- Coordinate submission activities for U.S. field actions
- Assist in Medical Device Licensing, Establishment Registrations, Device Listings
- Assist with general administrative responsibilities, such as setting up department meetings, filing, preparing regulatory submissions, tracking submission details and metrics, department communication
- Bachelor degree with major in engineering or life sciences
- Represent LATAM at Global RA Teams to ensure that regional demands are anchored into global RA Plans
- Support the timely execution of submission/approval plans in LATAM
Qualifications for regulatory affairs coordinator
- University degree in agricultural engineering, chemistry, animal breeding, veterinary or medicine
- Advanced English level is a must
- Negotiating power and influence
- Adaptation to change and management of ambiguous situations
- Ability to develop and implement an agenda for the change
- Decision making in critical situations (resolution of disputes)
3
Regulatory Affairs Coordinator Job Description
Job Description Example
Our growing company is looking to fill the role of regulatory affairs coordinator. 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 regulatory affairs coordinator
- Monitor globally agreed Key Performance Indicators (KPIs) in LATAM Region, drive measures on RA functional performance across RA in the Affiliates, and deliver regional reports as applicable
- Ensure processes are executed accordingly, aiming improvement and optimization as applicable
- Utilisation of RA systems and Support RA function in LATAM region for training and operational needs
- Represent LATAM at HQ groups responsible for development and/or implementation of projects and initiatives related to Regulatory processes and tools
- Provide regulatory assessment and insights in LATAM Region for regional projects and multidisciplinary initiatives
- Monitor competitors´ regulatory profile to support business strategies
- RA Intelligence, assessment of regulations in LATAM to ensure compliance and explore advocacy opportunities in cooperation with HQ/Affiliates
- Provides administrative support to the Product Compliance (Product Registrations) based in the Houghton Regis (UK) and San Antonio (USA) offices
- Coordinates requests for original and legalised documentation to support applications for international product licences
- Coordinates and maintains tracking data and metrics for registration requests, product licensing tasks, free sales certificates and legalisations
Qualifications for regulatory affairs coordinator
- Past experience on clinical trial or regulatory would be a plus
- Ability to innovate, analyze, understand customers’ needs with minimal supervision
- Proficient with computer systems and/or pharmaceutical software
- Able to work in a complex and matrix environment
- Knowledge of procedures and requirements regarding prescription drug advertising and promotional materials desired
- A Bachelor’s degree in a scientific or technical discipline is required or equivalent work experience
4
Regulatory Affairs Coordinator Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of regulatory affairs coordinator. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory affairs coordinator
- Provides information pertaining to product registration to SSUs, Design Owners, Solutions Management and other internal stakeholders as required
- Maintains updated tools for regulatory input into product development and maintenance, product licensing and related functions, based on information from members of the department
- Prepares basic documentation for medical device registrations as directed
- Submit regulatory medical device listing applications to international regulatory authorities as directed in accordance with agreed submission plans
- Raises purchase orders for non-stock purchasing within the department
- Act as point of contact to answer questions and support of activities related to operational/administrative tasks for preparation, submission and archiving of dossier
- Acquire knowledge of the local regulatory requirements in relation to projects assigned and gradually expand to general knowlegde of regulations and guidelines applicable to product registration and manufacture
- Interacts closely with and provides guidance to local/regional/global RA and GDM function, manufactuiring sites and other to obtain data required for projects assigned
- Develop, maintain and support cleaning of databases as directed for local/regional/global products
- Maintain and update regulatory files and records as required
Qualifications for regulatory affairs coordinator
- Knowledge of the medical device regulated environment
- Knowledge of applicable regulations and standards, 21 CFR 820, 801, 803, 806
- Must be able to manage several projects simultaneously
- Proficiency with Microsoft Office Products such as Word, Excel, Power Point, and SharePoint or equivalent software applications is preferred
- Must demonstrate effective research and analytical skills
- Assist ASEAN RA submission in 10 ASEAN countries
5
Regulatory Affairs Coordinator Job Description
Job Description Example
Our company is growing rapidly and is looking for a regulatory affairs coordinator. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory affairs coordinator
- Ensures compliance with local regulations and corporate policies and procedures as directed
- Support process improvements and implementation of best practices especially for archiving and other technical systems
- Assistes in preparation of regulatory deliverables (report generation, presentations)
- Maintain and coordinate general regulatory documentation, including the Regulatory file room and archives
- Assist in the development and update of Standard Operating Procedures (SOPs) and/or Current Best Practices, as required
- Be responsible for the Certificate and Sample registration activities for diverse portfolio of global drug products working with other functions across sites and departments
- Be responsible for requesting certificates from Health Agencies, manufacturing sites and other affiliate offices and ensuring documents are correct and available in a timely manner
- Coordinate notarization & legalization of documents (in many cases working with government agencies)
- Organize and dispatch documentation to global affiliates against strict timelines as part of the approval process for global submissions
- Organize, request and track orders for registration samples, working with regional and local regulatory affiliates and Global Supply Chain personnel
Qualifications for regulatory affairs coordinator
- Assist ASEAN RA maintain RA database and trackers
- Extensive experience in working within a corporate team at a medium-large company
- High degree of proficiency with Microsoft Excel as this is the tool used for daily data management
- Ability to render clear and accurate judgements, make and document decisions and work independently
- Knowledge and understanding of regulatory submission requirements, eCTD format, and other related material is essential
- Must be fully cognizant of and responsive to shifting priorities and be able to interact with professional staff