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Career Details
11-9199.01 - Regulatory Affairs Managers
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
Key Facts

Tasks

Core
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Establish regulatory priorities or budgets and allocate resources and workloads.
- Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Manage activities such as audits, regulatory agency inspections, or product recalls.
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
- Participate in the development or implementation of clinical trial protocols.
- Provide responses to regulatory agencies regarding product information or issues.
- Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
- Train staff in regulatory policies or procedures.
- Contribute to the development or implementation of business unit strategic and operating plans.
- Coordinate internal discoveries and depositions with legal department staff.
- Develop and maintain standard operating procedures or local working practices.
- Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
- Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.
- Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
- Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
- Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
Supplemental
- Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
- Monitor regulatory affairs trends related to environmental issues.
Knowledge

- 84%Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
- 81%Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
- 73%Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
- 65%Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
- 64%Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
- 63%Knowledge of principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects.
- 60%Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.
- 60%Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
- 59%Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
- 58%Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
- 58%Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods.
- 53%Knowledge of the practical application of engineering science and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of various goods and services.
- 52%Knowledge of principles and procedures for personnel recruitment, selection, training, compensation and benefits, labor relations and negotiation, and personnel information systems.
- 51%Knowledge of design techniques, tools, and principles involved in production of precision technical plans, blueprints, drawings, and models.
Tools

- Computer laser printers
- Desktop computers
- Laptop computers
- Personal computers
- Laser facsimile machines
- Photocopying equipment
- Multi-line telephone systems
Technology

- Adlib Express
- Adobe Systems Adobe AcrobatHOT
- Axway eSubmissions
- Datafarm a-Pulse
- Datafarm eCTDGatekeeper
- Datafarm eCTDViewer
- Datafarm S-Cubed
- DoubleBridge ROSETTA Phoenix eCTD Viewer
- DoubleBridge ROSETTA Pyramid
- DoubleBridge ROSETTA Sceptre
- DoubleBridge ROSETTA Scribe
- Electronic common technical document eCTD software
- Electronic common technical document eCTD validating software
- Electronic common technical document eCTD viewing software
- Electronic document management system EDMS
- Enterprise content management ECM software
- Extedo DOCvalidator
- Extedo eCTDmanager Suite
- Extedo PLmanager
- GlobalSubmit REVIEW
- GlobalSubmit VALIDATE
- Image Solutions eCTDXpress
- Image Solutions ISIPublisher
- Lorenz DocuBridge
- Lorenz eValidator
- Lorenz labelBridge
- MedXView eCTDauditor
- Octagon StartingPoint
- Octagon ViewPoint eCTD Complete
- Take Solutions PharmaReady Document Management System
- Thomson Reuters Liquent CoreDossier Submission Accelerator for eCTD
- Virtify eCTD
- Analyse-it
- Aris Global Register
- MasterControl software
- MediRegs E-dition Compliance Monitor
- MediRegs Pharmaceutical Regulation Suite
- MediRegs Regulation and Reimbursement Suite
- MediRegs Risk Assessment Manager
- Pilgrim Regulatory Submission
- Risk management software
- Samarind RMS
- SAP EHS Management
- Statistical analysis software
- Thomson Reuters Liquent InSight Suite
- Database software
- Dialog DialogLink
- Microsoft AccessHOT
- Structured query language SQLHOT
- TableauHOT
- Document publishing software
- Microsoft ExcelHOT
- Microsoft PowerPointHOT
- Microsoft VisioHOT
- Microsoft WordHOT
- Spreadsheet software
- Word processing software
- IBM NotesHOT
- Microsoft OutlookHOT
- Integrated development environment IDE softwareHOT
- Software development tools
- XML authoring software
- Microsoft OfficeHOT
- Microsoft ProjectHOT
- Microsoft SharePointHOT
- Total quality management TQM software
- Microsoft WindowsHOT
- Web browser software
Certifications

- SES Standards Professional Certification13340 SW 96th Ave, Miami, FL 33176
- Regulatory Affairs Certification - US5635 Fishers Lane, Suite 500, Rockville, MD 20852
- Certification for Institutional Review Board (IRB) Professionals
- Credit Union Compliance Expert5710 Mineral Point Road, Madison, WI 53701-0333
- Certified Dangerous Goods Professional11900 Parklawn Drive, Suite 450, Rockville, MD 20852
- Certified FISMA Compliance Practitioner
- Certified Community Bank Compliance Officer1615 L Street NW, Suite 900 Washington, D.C., DC 20036
- Certified BSA/AML Professional1615 L Street NW, Suite 900 Washington, D.C., DC 20036
Licensing

Related Programs

Clicking on the Degree programs in the list below will take you away from the Careers page.
The curriculum is designed for persons who seek employment in the accounting field or for those presently in accounting who wish to increase their knowledge and update their skills. Job opportunities include accounting trainee, accounting technician, junior accountant, and accountant.
This degree is excellent for those interested in the organization and reporting of financial data. Upon completion of the program, students can take an additional three courses for the Accounting Career Studies Certificate, and then are eligible to proceed to the CPA exam, if other education requirements are satisfied. Contact the Virginia Board of Accountancy for all education requirements.
This curriculum is designed for individuals who plan to transfer to a four-year college or university to complete a baccalaureate degree program in business administration with a major in accounting, business management, decision science and management, information systems, finance, marketing, etc.
The curriculum is designed for individuals who seek employment in business management or for those presently in management who are seeking promotion. Job opportunities include administrative assistant, management trainee, department head, branch manager, office manager, manager of small business, and supervisor.
The curriculum is designed to provide a broad foundation that will prepare students to enter any of the varied fields in criminal justice or to prepare for professional advancement. Job opportunities for students include local, state, and federal enforcement officers, police officers, private or government investigators, adult/juvenile correction officers, probation/parole officers and counselors, security directors (managers), loss prevention directors, classification managers, and personnel clearance administrators. Most of the ADJ courses in this curriculum are 'core courses' that provide a basic entry-level foundation in both criminal justice and security administration. These courses must be taken by ALL STUDENTS in this program. At several points in the curriculum, 'course options' are provided for selection by the students.
Special Curriculum Admission Requirements: Students are advised that many criminal justice and private/government security agencies require excellent moral character and a written record of conduct prior to consideration for employment.
This curriculum is designed for those students who wish to take only those courses that relate directly to the law enforcement field. The occupational objectives are to provide a basic foundation for individuals entering some particular area of the criminal justice field that does not require an A.A.S. or higher degree in criminal justice, or for persons already in the criminal justice field who wish to extend their knowledge/skill, or for those exploring the criminal justice field as a career alternative. Courses taken in the certificate program can be applied to the A.A.S. degree.
Special Curriculum Admission Requirements: Students are advised that many criminal justice and private/government security agencies require excellent moral character and a written record of conduct prior to consideration for employment.
This program is designed to prepare students to transfer to a four-year college or university to complete a baccalaureate degree program in criminal justice, criminology, or related fields.
Purpose This curriculum prepares students to transfer to any four-year college or university teacher preparation program. Courses in this degree are designed to satisfy some of the endorsement and professional course requirements of a Virginia teaching license. In EDU 200, students will identify the endorsement (content) courses they need to earn a teaching license. Students should meet with a Teacher Education faculty member or Education Field Placement Coordinator and Advising Specialist to select the correct courses for their area of licensure. EDU 200 and EDU 204 both require 20-hour field placements in a K-12 public school. Students will be required to complete a background check before being placed in the schools. Students with criminal records should consult with the Teacher Education Field Placement Coordinator before enrolling in the courses. Students are strongly encouraged to take the VCLA after completing ENG 111, ENG 112, Eng-literature course, and CST 100 or 110.
This program is a flexible associate degree. For students who plan to transfer, the degree can parallel the first two years of a four-year bachelor of science program if they choose courses that match the transfer institution's requirements. For those students who do not plan to transfer, the degree allows them to structure a program to suit their needs using accumulated credits from a variety of formal and experiential sources.
This program is designed for individuals who plan to transfer to a four-year institution to complete a bachelor of arts (B.A.).
This program is designed for students who plan to transfer to a college or university for a Bachelor of Arts in Art History.
This program is designed to prepare students to transfer into baccalaureate programs in the geospatial or social sciences at a four-year institution. Students will learn theory about geospatial systems and how they are used.
This program is designed for individuals who plan to transfer to a four-year college or university to complete a baccalaureate degree. Graduates will have the knowledge, skills, and abilities equivalent to students entering the junior level at four-year colleges and universities.
Students with a baccalaureate degree who wish to pursue the Certified Public Accountant (CPA) examination may use specific course work toward fulfillment of accounting educational requirements. Some course work also meets federal government guidelines for those interested in qualifying for positions or promotions in the federal government. Students should consult an accounting instructor to determine the courses that meet the educational requirements.
The Associate of Applied Science (A.A.S.) degree provides students with a strong foundation in accounting and business, along with general education requirements, enabling students to seek entry-level employment in accounting. In addition, the course work prepares students for certification exams.
The certificate programs provide course work that gives students the skills to sit for one or more certification exams administered by the Accreditation Council for Accountancy and Taxation (ACAT).
Students completing the A.A.S. in Management have opportunities to transfer to four-year universities to pursue B.S. degrees in Business Administration, Management, and related areas. See https://www.tcc.edu/programs/transfer/transfer-agreements/ for agreements.
Courses required for the Business Administration degree are available on all four campuses.
Students are advised to consult with the program coordinator prior to entering the program.
For those who wish to continue their education pursuits beyond the associate degree, Tidewater Community College has entered into formal articulation agreements with colleges and universities to ease transfer. Individuals interested in this option are encouraged to consult with a TCC advisor early in their academic program.
Courses required for the Liberal Arts degree are available on all four campuses.
Courses required for the General Studies degree are available on all four campuses.
Courses required for the Social Sciences degree are available on all four campuses.