IQVIA is hiring a Regulatory Affairs Officer in Bangalore. With 3.5 to 7 years of experience in regulatory affairs and a background in Life Sciences or Pharmacy, you can join a leading global provider of advanced analytics, technology solutions, and clinical research services. Discover the opportunity to make a significant impact in the field of regulatory affairs and be part of a team that pushes the boundaries of human and data science.
About IQVIA
IQVIA is a renowned global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. Our mission is to help customers create a healthier world by leveraging the power of human and data science. We are committed to innovation, excellence, and making a positive impact on global health.
Job Responsibilities
As a Regulatory Affairs Officer at IQVIA, you will be responsible for:
- 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-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.
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IQVIA Hiring Regulatory Affairs Officer - Bangalore[/caption]
Qualifications
To be considered for this role, you must have:
- Experience: 3.5 to 7 years of relevant experience in regulatory affairs.
- Educational Background: A degree in Life Sciences (BSc or MSc) or Pharmacy (BPharm).
- Technical Skills: Proficiency with MS-Office Suite, Adobe Acrobat applications, and knowledge of Electronic Document Management Systems. Experience with electronic publishing systems and software such as RIM Smart, Insight, eCTDXpress, Extedo, and Lorenz.
- Soft Skills: Excellent time management skills, ability to work independently or in teams, and strong communication skills.
Application Process
If you are a qualified candidate with the required experience and skills, we encourage you to apply for this exciting opportunity at IQVIA. Apply through the IQVIA Referral Link:
Apply Now
https://pharmastuff.org.in/job/iqvia-hiring-regulatory-affairs-officer-bangalore
