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Regulatory Affairs Specialist Interview Questions

This regulatory affairs specialist interview questions and answers example uses common expected ques. that your recruiter may ask, and includes related answers for showing you how to replay.
See also: Strengths and Weaknesses Interview Question
» Ques & Answers Examples for Regulatory Affairs Specialist

Question [1]:
What are the main job duties and responsibilities of "regulatory affairs specialist" employee?

Answer [1]:
Regulatory affairs specialist responsibilities are to 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.

Question [2]:
What are the skills required from regulatory affairs specialist employee in order to success in his work?

Answer [2]:
Understanding written sentences and paragraphs in work related documents, Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems, Communicating effectively in writing as appropriate for the needs of the audience, Talking to others to convey information effectively, 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.

Question [3]:
Describe the abilities you have in order to work with us as regulatory affairs specialist?

Answer [3]:
I have the ability to read and understand information and ideas presented in writing, communicate information and ideas in writing so others will understand, listen to and understand information and ideas presented through spoken words and sentences, communicate information and ideas in speaking so others will understand, tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem.

Question [4]:
What are the knowledge elements you obtained from your education, training and work experience would support your regulatory affairs specialist career?

Answer [4]:
The knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar, laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process, 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, circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming, business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.

Question [5]:
How would you describe (regulatory affairs specialist or your) needed work style?

Answer [5]:
My work style matching exactlty what cashier job requires by: being honest and ethical, being careful about detail and thorough in completing work tasks, being reliable, responsible, and dependable, and fulfilling obligations, being open to change (positive or negative) and to considerable variety in the workplace, analyzing information and using logic to address work-related issues and problems.

Other regulatory affairs specialist interview questions to expect:

Tell about yourself and why you think you are successful regulatory affairs specialist?

Why do you like to work as regulatory affairs specialist?

What could you do not like to work as regulatory affairs specialist?

What are your future steps after experience you'll gain from your regulatory affairs specialist job?

As regulatory affairs specialist, what training courses or extra education that you think will improve your work performance?

What salary do you expect you'll get from being regulatory affairs specialist employee?

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