Reg Affairs Officer 1

PURPOSE

Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. Provides regulatory support for assigned projects.

RESPONSIBILITIES

• Acts as a Regulatory Team Leader on small, straightforward regulatory projects and/or becomes 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 and management of budget for any given project.

• May prepare slides and background material for small, straightforward business development meetings under senior guidance and present to clients at bid defence meetings by phone or in person.

• May prepare and deliver training, as appropriate.

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

All responsibilities are essential job functions unless noted as nonessential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

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

Strong software and computer skills, including MS Office applications

Demonstrates self-motivation and enthusiasm

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

Ability to follow SOPs consistently; provides independent thought to assist in process improvements

Ability to make decisions on discrete tasks under senior supervision

Ability to establish and maintain effective working relationships with co-workers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Degree in life science-related discipline or professional equivalent plus at least 1 year relevant experience* or high school diploma plus at least 5-7 years experience* (*or combination of education, training and experience)

PHYSICAL REQUIREMENTS

Extensive use of telephone and face-to-face communication requiring accurate perception of speech

Extensive use of keyboard requiring repetitive motion of fingers

Regular sitting for extended periods of time

Travel will be required

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.