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

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

- Microsoft ProjectHOT
- Microsoft SharePointHOT
- Total quality management TQM software
- Microsoft OfficeHOT
- Microsoft VisioHOT
- Microsoft WordHOT
- Word processing software
- Microsoft PowerPointHOT
- Microsoft ExcelHOT
- Spreadsheet software
- Document publishing software
- Adlib Express
- Adobe Systems Adobe AcrobatHOT
- Axway eSubmissions
- Datafarm S-Cubed
- Datafarm a-Pulse
- Datafarm eCTDGatekeeper
- Datafarm eCTDViewer
- 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 PLmanager
- Extedo eCTDmanager Suite
- GlobalSubmit REVIEW
- GlobalSubmit VALIDATE
- Image Solutions ISIPublisher
- Image Solutions eCTDXpress
- 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
- Database software
- Microsoft AccessHOT
- Structured query language SQLHOT
- Dialog DialogLink
- TableauHOT
- Integrated development environment IDE softwareHOT
- Software development tools
- XML authoring software
- Analyse-it
- Risk management software
- Statistical analysis software
- 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
- SAP EHS Management
- Samarind RMS
- Thomson Reuters Liquent InSight Suite
- Web browser software
- Microsoft WindowsHOT
- IBM NotesHOT
- Microsoft OutlookHOT
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.
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.
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.
This curriculum is designed for individuals who plan to seek employment in contract management positions and for those presently in contract management positions who seek career advancement. The program is designed to create opportunities for positions in contract management for both government agencies and private industry. Instruction includes both the theoretical concepts and the practical applications needed for future success in the contract management field. This will provide a greater understanding of acquisition, life cycle management, and contracting processes. Job opportunities include project manager, procurement analyst, contract administrator, contract specialist, contract negotiator, contract price analyst, and contract termination specialist.
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 program prepares students for entry-level opportunities as a local, state, or federal law enforcement officer; commercial and industrial security officer; police officer; or private or government investigator, particularly in the areas of homeland security.
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.
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 to prepare students who intend to transfer to a four-year institution to complete a bachelor's degree in international studies. This specialization will broaden the student's education to include more emphasis on other cultures and countries in recognition of the increasing interdependence of today's world.
This curriculum is designed for students who plan to transfer to a college or university for a BS or B.A. degree in psychology.
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 college or university to complete a bachelor of science in one of the social sciences. It also prepares students for some teacher certification programs. Students from the A.S. program major in a wide variety of fields, including anthropology, economics, government/political science, history, mass communications, pre-law, psychology, public administration, social work, and sociology.
This curriculum prepares students to transfer to a four-year college or university teacher preparation program. It is specifically designed for students who plan to seek endorsement and licensure as teachers in PK-3, PK-6, middle school, or special education.
This degree program is designed to help students earn all of the required endorsement course hours for a teaching license in elementary education for the state of Virginia. In addition, this degree program includes many of the required endorsement courses for licensure in middle school (any subject) and high school history and social sciences. Some of these universities will guarantee admission to graduates of this program who have a cumulative GPA of at least 2.5, earn at least a 'C' in all English courses. Students are strongly encouraged to take the VCLA exam shortly after completing their 200-level English course. Students may want to take the Praxis CORE math exam after completing 9-12 hours of mathematics. The student, working directly with a NOVA Teacher Education Specialization advisor/counselor, should complete a transfer letter of agreement.
This program is designed for individuals who plan to transfer to a four-year college or university to complete a bachelor of science in a program that requires a background in American Sign Language and the Deaf community. Graduates may use their skills to work in human service fields such as daycare settings and as teacher assistants. Graduates from the program can also transfer to 4-year institutions and major in a wide variety of fields, including ASL instruction, Deaf education, linguistics, Deaf studies (e.g. history, literature, research, etc.), speech-language pathology and audiology, human services, communication sciences and disorders, and social work.
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.
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.
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This program is designed to help students develop both the theoretical knowledge and a practical facility with GIS. Students who already hold a baccalaureate or master's degree will acquire the requisite skills and knowledge to switch careers, or to apply spatial analysis in their present workplaces. Students will be positioned to pursue additional coursework toward an associate degree and/or transfer to a four-year institution for further study in the geospatial, environmental, or physical sciences; in civil engineering; in information technology; or in business/marketing at a four-year institution.
Preparation: Students are expected to understand fundamental computer applications and concepts before enrolling in GIS courses.
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.
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.
Students are advised to consult with the program coordinator prior to entering the 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.
Graduates of the maritime logistics program may enter or continue employment in the field of logistics management in maritime or traditional business environments.
Students planning to pursue a B.S. in Business Administration from a four-year college/university are advised to pursue TCC's general A.S. degree in Business Administration (plan code 213).
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