We at Parexel are hiring for multiple positions in Regulatory Affairs- Submission Publishing.
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.
Qualification
B.Pharm- Regulatory Affairs/M. Pharm- Regulatory Affairs
