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IQVIA
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Regulatory Affairs Officer

Regulatory Affairs Officer

IQVIA

2 years

0 Lacs

Bengaluru, Karnataka

Posted:3 days ago| Platform: SimplyHired logo

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Skills Required

Research Microsoft Office Master's degree Bachelor's degree Computer skills

Work Mode

On-site

Job Type

Full Time

Job Description

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;
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;

Qualifications

Bachelor's Degree Degree in Lifescience or related discipline Req Or
Master's Degree Degree in Lifescience 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 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 porcedures 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

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

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Regulatory Affairs Officer