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:

  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
  • Participate in internal or external audits.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Review clinical protocols to ensure collection of data needed for regulatory submissions.
  • Write or update standard operating procedures, work instructions, or policies.
  • 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.
  • Develop or conduct employee regulatory training.
  • 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.
  • Recommend changes to company procedures in response to changes in regulations or standards.
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Coordinate recall or market withdrawal activities as necessary.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
  • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
  • Recommend adjudication of product complaints.
  • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
  • Develop or track quality metrics.
  • Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
  • Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
  • Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
  • Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
  • Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
  • Monitor national or international legislation on ozone-depleting substances or global warming.
  • Obtain clearances for the use of recycled plastics in product packaging.

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.

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

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.

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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.

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

Staffing Organizational Units - Recruiting, interviewing, selecting, hiring, and promoting employees in an organization.

Monitoring and Controlling Resources - Monitoring and controlling resources and overseeing the spending of money.

Holland Code Chart for a Regulatory Affairs Specialist