IQVIA Walk-in Interview 2022 BSc to MSc, Bpharm for Regulatory Affairs Officer At Bangalore, India . IQVIA Notification full details below.Interested and eligible candidates send Your Resume.
- Vacancy details:
- Post Name: Regulatory Affairs Officer
- Qualification: BSc to MSc, Bpharm
- Experienced:3.5 to 7 yrs
Job Description: IQVIA Hiring For Regulatory Affairs Officer !
- Important Details :
- Location: Bangalore, India
- Post of date:13/03/2022
- Selection Process: The selection will be on the basis of Interview.
Essential Functions
∙ Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including NDAs, INDs, 510(k)s, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, etc.
∙ Support Regulatory Affairs personnel in the coordination, preparation, and submission of all above submissions.
∙ Responsible for the pre-publishing (Bookmarks and Hyperlinks), compilation, post publishing, Validation of Regulatory submissions and lifecycle management submissions.
∙ Identifies project needs, tracks project timelines, implements client requests and manages day[1]to-day workload in collaboration with senior staff, as appropriate;
∙ Perform QC process to ensure the integrity and quality of each published unit.
∙ Planning, preparing, tracking, and archiving regulatory documents and submissions in paper and electronic formats.
∙ Responsible for maintenance of all Regulatory and FDA correspondence (distributing, filing into electronic document management system) within specified time frames.
∙ Liaise with functional source areas (clinical, nonclinical, CMC, regulatory) to ensure documents are compliant with authoring style guide. “Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications”.
∙ Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters.
∙ Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the US FDA, EMEA and ICH.
∙ May represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
∙ Keep close interaction with authoring community to track availability of deliverables.
∙ Technical knowledge of electronic publishing systems and software (RIM Smart, Insight, eCTDXpress, Extedo, Lorenz)
∙ May prepare and deliver trainings, as appropriate.
∙ Proficiency with MS-Office Suite and Adobe Acrobat applications, Knowledge of Electronic Document Management Systems.
∙ Responsible in solving day to day queries of the team members.
∙ Self-starter with superior time management skills, and ability to work independently or in teams
∙ Performs other tasks or assignments, as delegated by Regulatory management
How to Apply :
Step 1: Click on below link and you will be redirected to Career Page of Recruiting Company or Career portal.
Step 2. Register on Career Page of the Company or Career Portal by giving log in credentials and other personal or education details .
Step 3.Upon successful registration .User need to log in with credentials.
Step 4.Once logged in, User need to fill the all relevant personal ,educational , Work experience details ,attach resume and submit application form.
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