Regulatory Affairs Specialist Career

Job 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.


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Regulatory Affairs Specialist Career

What Regulatory Affairs Specialists do:

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

What work activities are most important?

Importance Activities

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.

Getting Information - Observing, receiving, and otherwise obtaining information from all relevant sources.

Updating and Using Relevant Knowledge - Keeping up-to-date technically and applying new knowledge to your job.

Interacting With Computers - Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.

Communicating with Supervisors, Peers, or Subordinates - Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.

Organizing, Planning, and Prioritizing Work - Developing specific goals and plans to prioritize, organize, and accomplish your work.

Processing Information - Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.

Interpreting the Meaning of Information for Others - Translating or explaining what information means and how it can be used.

Making Decisions and Solving Problems - Analyzing information and evaluating results to choose the best solution and solve problems.

Establishing and Maintaining Interpersonal Relationships - Developing constructive and cooperative working relationships with others, and maintaining them over time.

Communicating with Persons Outside 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.

Documenting/Recording Information - Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.

Identifying Objects, Actions, and Events - Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.

Analyzing Data or Information - Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.

Performing Administrative Activities - Performing day-to-day administrative tasks such as maintaining information files and processing paperwork.

Developing Objectives and Strategies - Establishing long-range objectives and specifying the strategies and actions to achieve them.

Provide Consultation and Advice to Others - Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.

Coordinating the Work and Activities of Others - Getting members of a group to work together to accomplish tasks.

Developing and Building Teams - Encouraging and building mutual trust, respect, and cooperation among team members.

Scheduling Work and Activities - Scheduling events, programs, and activities, as well as the work of others.

Monitor Processes, Materials, or Surroundings - Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems.

Resolving Conflicts and Negotiating with Others - Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.

Training and Teaching Others - Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.

Judging the Qualities of Things, Services, or People - Assessing the value, importance, or quality of things or people.

Thinking Creatively - Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions.

Estimating the Quantifiable Characteristics of Products, Events, or Information - Estimating sizes, distances, and quantities; or determining time, costs, resources, or materials needed to perform a work activity.

Coaching and Developing Others - Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.

Selling or Influencing Others - Convincing others to buy merchandise/goods or to otherwise change their minds or actions.

Guiding, Directing, and Motivating Subordinates - Providing guidance and direction to subordinates, including setting performance standards and monitoring performance.

Holland Code Chart for a Regulatory Affairs Specialist

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