India's DMPLOI - Jobs & Networking App
Are you looking for a new career challenge? Look no further as we are seeking new personnel to join our growing team as we continue working to drive better outcomes for drug development. We have exciting opportunities available across the globe with a mix of office, remote, and hybrid working available.
Junior Regulatory Associate
Location: Chennai, India
Education: Bachelor’s Degree in Pharma
Regulatory Affairs
Full Time
Job Description:
We are looking for a Junior Regulatory Associate to support our Publishing and Submissions team. The applicant must be able to:
- Understand the requirements for various regulatory submissions including, but not limited to: IND, ANDA, NDA, and DMF in CTD/eCTD formats for a number of regulatory agencies including the US-FDA, EMA, Health Canada, etc.
- Assist Regulatory Associates/Senior Regulatory Associates in document level publishing, including bookmarking, hypertext linking, and preparing Tables of Contents as per the guidelines.
- Carry out Submission Publishing Support, archiving and/or review of same day dispatch, major/complex submissions
- Ensure compliance with customer SOP’s and Policies as well as adhere to the organization’s policies and procedures
Desirable Skills and Experience
- Experience in Publishing and Submissions is required.
If you are a passionate life science professional, please click here:
https://lnkd.in/g4f5wpQQ to learn more and apply to take a seat at our table!
