Regulatory Affairs Managers
What is a Regulatory Affairs Manager?
A Regulatory Affairs Manager is a professional responsible for ensuring that companies comply with all of the regulations and laws pertaining to their business. They act as a bridge between the organization and regulatory bodies, ensuring that the development, manufacturing, and marketing of products run smoothly and in accordance with legal and statutory requirements. Regulatory Affairs Managers play a critical role in industries such as pharmaceuticals, biotechnology, medical devices, and food safety, where compliance with government regulations is paramount for product approval and market access. Their role involves preparing and submitting documentation to regulatory agencies, maintaining product registrations, and overseeing quality control processes. They must stay informed about changes in regulations and ensure that the company’s practices are aligned with these changes. This position often requires extensive knowledge of scientific, legal, and regulatory information, as well as strong communication and project management skills. As the landscape of regulations frequently evolves, Regulatory Affairs Managers must continually adapt their strategies to meet new guidelines and ensure that their organization remains compliant while achieving its business objectives.
Tasks
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
- Provide responses to regulatory agencies regarding product information or issues.
Technology Skills
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Document management software
- Adlib Express
- Adobe Acrobat
- Axway eSubmissions
- Virtify eCTD
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Presentation software
- Microsoft PowerPoint
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Compliance software
- Aris Global Register
- MediRegs E-dition Compliance Monitor
- SAP EHS Management
- Thomson Reuters Liquent InSight Suite
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Data base user interface and query software
- Database software
- Microsoft Access
- Structured query language SQL
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Risk management data and analysis software
- MasterControl software
- Risk management software
Tools Used
- Photocopiers
- Notebook computers
- Laser printers
- Special purpose telephones
- Laser fax machine
Knowledge
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English Language
Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
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Law and Government
Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
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Administration and Management
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.
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Biology
Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
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Education and Training
Knowledge of principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects.
Skills
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Writing
Communicating effectively in writing as appropriate for the needs of the audience.
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Reading Comprehension
Understanding written sentences and paragraphs in work-related documents.
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Active Listening
Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
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Speaking
Talking to others to convey information effectively.
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Critical Thinking
Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
Abilities
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Written Expression
The ability to communicate information and ideas in writing so others will understand.
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Oral Comprehension
The ability to listen to and understand information and ideas presented through spoken words and sentences.
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Oral Expression
The ability to communicate information and ideas in speaking so others will understand.
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Written Comprehension
The ability to read and understand information and ideas presented in writing.
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Deductive Reasoning
The ability to apply general rules to specific problems to produce answers that make sense.
Education
How much education does a new hire need to perform a job in this occupation?
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Bachelor's degree
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Master's degree
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Some college, no degree
Work Activities
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Evaluating Information to Determine Compliance with Standards
Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
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Communicating with People Outside the Organization
Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.
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Communicating with Supervisors, Peers, or Subordinates
Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
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Interpreting the Meaning of Information for Others
Translating or explaining what information means and how it can be used.
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Getting Information
Observing, receiving, and otherwise obtaining information from all relevant sources.
Detailed Work Activities
- Develop operating strategies, plans, or procedures.
- Review documents or materials for compliance with policies or regulations.
- Manage control system activities in organizations.
- Maintain regulatory or compliance documentation.
- Prepare reports related to compliance matters.
Work Interests
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Enterprising
Work involves managing, negotiating, marketing, or selling, typically in a business setting, or leading or advising people in political and legal situations. Enterprising occupations are often associated with business initiatives, sales, marketing/advertising, finance, management/administration, professional advising, public speaking, politics, or law.
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Conventional
Work involves following procedures and regulations to organize information or data, typically in a business setting. Conventional occupations are often associated with office work, accounting, mathematics/statistics, information technology, finance, or human resources.
Job Outlook
Projected salary and job growth
$67370.0 - $225120.0
This career will grow rapidly in the next few years and will have large numbers of openings.
Assessment
Related assessments and tests
No assessment available.