Senior Regulatory Affairs Officer

Job Overview Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects.

• Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff;
• Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate;
• Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;
• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;

• Must have a Bachelors Degree Degree in Life Science or related discipline;
• Must have a Masters Degree Degree in Life Science or related discipline;
• At least 2 years relevant experience.

Key skills

• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
• Good, solid interpersonal communication (oral and written) and organisation skills;
• Ability to establish and maintain effective working relationships with coworkers, managers and clients;
• Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable;
• Ability to work on several projects, with direction from senior staff as appropriate;
• Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

Information :

• Company : IQVIA
• Position : Senior Regulatory Affairs Officer
• Location : Cairo
• Country : EG