At Parexel, we all share the same goal – to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special – a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.
Name of Position: Regulatory Affair Associate
Qualification: B. Pharma/ M. Pharma
Experience: 2 to 4 Years
Job Responsibilities:
- 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.
2.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.
6.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.
Location: Bengaluru
Selection Process: On the basis of Interview
Mode of Interview: Face to face including HR rounds
Post Date: 25 April 2023
Connect with Us
Click here to follow Us On Instagram
Click here to follow us on Facebook
Click here to follow us on Telegram Channel
