Sample interview questions: Have you ever been involved in the preparation and submission of marketing authorization applications for medical research products targeting rare ophthalmological disorders?
Sample answer:
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Experience in preparing and submitting marketing authorization applications (MAAs) for medical research products targeting rare ophthalmological disorders. This includes experience in working with regulatory authorities in different countries, as well as experience in preparing and submitting clinical trial applications (CTAs).
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Strong understanding of the regulatory requirements for medical research products in different countries, including knowledge of the different types of MAAs, the data required to support an MAA, and the review process. It also includes knowledge of the regulatory requirements for clinical trials, such as the Good Clinical Practice (GCP) guidelines.
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Excellent communication and interpersonal skills, with the ability to work effectively with regulatory authorities, clinical research teams, and other stakeholders. This includes the ability to clearly and concisely communicate complex scientific and regulatory information.
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Ability to work independently and as part of a team, with the ability to meet deadlines and manage multiple projects simultaneously.
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Up-to-date knowledge of the latest advances in ophthalmology and medical research. This includes knowledge of the latest clinical trial results, as well as the latest regulatory developments.
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Ability to provide strategic advice on regulatory matters … Read full answer
Source: https://hireabo.com/job/2_3_19/Regulatory%20Affairs%20Specialist