Regulatory Officer Vacancy In Iqvia

Hiring Organization / Company: Iqvia
Basic Salary: To Be Discussed
Employement Type: Full-Time



Job Details:

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

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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.




Job Location Information:
City: Mumbai
State: Mh
Country: In
Location: Mumbai, Maharashtra

Date Posted: 2021-09-15
Job Listing No# : 182711


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