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Career Description

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.

What Job Titles Regulatory Affairs Specialists Might Have

• Drug Regulatory Affairs Specialist
• Regulatory Affairs Associate
• Regulatory Affairs Specialist
• Regulatory Submissions Associate

What Regulatory Affairs Specialists Do

• Coordinate, prepare, or review regulatory submissions for domestic or international projects.
• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
• Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
• Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
• Prepare or maintain technical files as necessary to obtain and sustain product approval.
• Coordinate efforts associated with the preparation of regulatory documents or submissions.
• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
• Analyze product complaints and make recommendations regarding their reportability.
• Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
• Review clinical protocols to ensure collection of data needed for regulatory submissions.
• Compile and maintain regulatory documentation databases or systems.
• Recommend changes to company procedures in response to changes in regulations or standards.
• Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
• Write or update standard operating procedures, work instructions, or policies.
• Participate in internal or external audits.
• Develop or conduct employee regulatory training.
• Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
• Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
• Coordinate recall or market withdrawal activities as necessary.
• Direct the collection and preparation of laboratory samples as requested by regulatory agencies.

What Regulatory Affairs Specialists Should Be Good At

• Written Comprehension - The ability to read and understand information and ideas presented in writing.
• Written Expression - The ability to communicate information and ideas in writing so others will understand.
• Oral Comprehension - The ability to listen to and understand information and ideas presented through spoken words and sentences.
• Oral Expression - The ability to communicate information and ideas in speaking so others will understand.
• Problem Sensitivity - The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem.
• Deductive Reasoning - The ability to apply general rules to specific problems to produce answers that make sense.
• Inductive Reasoning - The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
• Information Ordering - The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
• Near Vision - The ability to see details at close range (within a few feet of the observer).
• Speech Clarity - The ability to speak clearly so others can understand you.

What Regulatory Affairs Specialists Need to Learn

• English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
• Law and Government - Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
• Clerical - 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.