Example Career: Regulatory Affairs Specialists

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

• Regulatory Affairs Associate (RA Associate)
• Regulatory Affairs Consultant (RA Consultant)
• Regulatory Affairs Specialist (RA Specialist)
• Regulatory Engineer

What Regulatory Affairs Specialists Do

• Coordinate efforts associated with the preparation of regulatory documents or submissions.
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
• Coordinate, prepare, or review regulatory submissions for domestic or international projects.
• Prepare or maintain technical files as necessary to obtain and sustain product approval.
• 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.
• Coordinate recall or market withdrawal activities as necessary.
• Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
• Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
• Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
• Identify relevant guidance documents, international standards, or consensus standards.
• Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Review clinical protocols to ensure collection of data needed for regulatory submissions.
• Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Recommend changes to company procedures in response to changes in regulations or standards.
• Participate in internal or external audits.
• Compile and maintain regulatory documentation databases or systems.
• Write or update standard operating procedures, work instructions, or policies.
• Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
• Develop or track quality metrics.
• Develop or conduct employee regulatory training.
• Recommend adjudication of product complaints.
• Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
• 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.