Regulatory Affairs Officer 1 (13-Months Contract)

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.

Essential Functions:

• 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.

• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.

• Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters.

• Understands the Scope of Work, deliverables for any given project.

• May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person.

• May prepare and deliver trainings, as appropriate.

• Performs other tasks or assignments, as delegated by Regulatory management.

• Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex.

Qualifications:

• Bachelor's Degree in Life Science or related discipline

• 3 years of Regulatory Affairs experience (drug and medical devices), including Thai FDA liaison/submissions.  

• Experience in medical device registration and product advertising/ promotional regulatory compliance is preferred.

• 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.

• Demonstrates self-motivation and enthusiasm.

• Ability to work on several projects, with direction from senior staff as appropriate.

• Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements.

• Ability to make decisions on discrete tasks under senior supervision.

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.