Regulatory Affairs Officer
hace 2 semanas
Join us in our exciting journey
We currently require a motivated, creative and enthusiastic Regulatory Affairs professional to join our in our
sponsor dedicated model.
With a fantastic work/life balance, this is a great opportunity for a Regulatory Affairs professional willing to discover what means to work in one of the best CROs worldwide A career with IQVIA connects you to great opportunity to achieve professional success and impact healthcare around the world.
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.
The role:
Responsibilities
- 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 daytoday 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;
- 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
- Bachelor's Degree Degree in Life science or related discipline Req Or
- Master's Degree Degree in Life science or related discipline Req
- At least 2 years relevant experience
- 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 organization skills;
- Ability to establish and maintain effective working relationships with coworkers, managers and clients;
- Demonstrates selfmotivation 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;
- Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
- Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
- Problems faced are general and may require understanding of broader set of issues, but typically are not complex;
- Applicable certifications and licenses as required by country, state, and/or other regulatory bodies
We invite you to join IQVIA
- Recognized by
Great Place to Work as the second best company to work for in Spain (March 2019)
FORTUNE Magazine's World's Most Admired Companies list for the fourth year in a row (January 2021)
- Recognized by the 2016 Scrip Awards as the
Best Fullservice Provider Contract Research Organization (CRO) - Awarded the 2016 Eagle Award from the Society for Clinical Research Sites (SCRS) for the fourth consecutive year.
- A sitenominated award recognizing contract research organizations (CRO) and biopharmaceutical sponsors dedicated to
building positive relationships with research sites through leadership, professionalism and integrity. - IQVIA named in The International Association of Outsourcing Professionals (IAOP) 2017 Global Outsourcing 100 List which recognizes the world's best service providers across a range of industries.
equal opportunity employer. We make employment decisions based on qualifications and merit. We prohibit discrimination based on any unlawful consideration such as age, race, national origin, gender or other "protected status."
We know that meaningful results require not only the right approach but also the right people. Regardless of your role,
we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and whatever your career goals, we are here to ensure you get there
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