Parexel Walk-in Interview 2023 /Parexel Notification full details below.Interested and eligible candidates can Send Resume.Parexel is focused on the development of innovative new therapies to improve the world’s health. We do this by providing a suite of groundbreaking biopharmaceutical development services that help customers across the globe transform scientific discoveries into new treatments for patients.
Vacancy details:
- Post Name: Regulatory Affairs Associate
- Qualification: B.Pharm- Regulatory Affairs/M. Pharm- Regulatory Affairs
- Experience: 2-4 yrs of experience
Job Description: Greeting from Parexel !!
- Important Details :
- Location: India-Bengaluru
- Post of date:25/04/2023
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face To Face Interview
- Interview Rounds of Interview: HR
We are looking for candidates with 2-4 yrs of experience in Submission Publishing willing to work in night shift and having knowledge in Paper, Nees and eCTD formats (US, EU, Saudi, Canada etc).
1.Regulatory activities include troubleshooting as well as dispatching the submissions to health authorities for various regions.
2. Should have knowledge on country specific requirements for submission publishing and up to date with the requirements.
3. Should ensure quality work and on time delivery meeting client and health authority deadlines.
Qualification-B.Pharm(Regulatory Affairs)/ M.Pharm(Regulatory Affairs) preferred.
Kindly apply to the below open positions.
1. Regulatory Affairs Associate- https://bit.ly/41A85iD
2. Regulatory Affairs Associate- https://bit.ly/3L1z8MD
3. Regulatory Affairs Associate- https://bit.ly/41Q8xc8
. 2-4 yrs of experience in a regulatory environment with preference given to drug/device/biologic-related industry, and experience with electronic publishing of regulatory submissions.
.Compilation, publishing, and technical quality control of Regulatory submissions
(Nees, paper and eCTD format) including technical troubleshooting to ensure issues within submissions are resolved and deadlines met.
. Creation of cross-references, table of content, tab / slip-sheets, and volumes for Paper submissions.
. Performing bookmarking, hyper-linking, and tables of content creation according to Health Authority (HA) guidelines for Electronic Submissions.
. Knowledge of medical/scientific terminology, ICH guidelines and regulations and procedures preferred. Knowledge of submission requirements of various markets such as USFDA, EMA etc. is preferable.
.Good communication, organizational, and interpersonal skills.
. Knowledge of submission dispatches to Health Authorities is preferrable.
. Word formatting using plug-ins such as starting point template/other template experience is preferable.
