Clinical Project Assistant
SanofiÂ
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Job Description
Designation: Junior Regulatory Associate
Company:Â Navitas Life Science
Qualifications: B. Pharmacy / M. Pharmacy / Pharm D / Life-Sciences
Years of Experience: 1-3 Years
Role & Responsibilities
- 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
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Educational Qualification
- B. Pharmacy / M. Pharmacy / Pharm D / Life-Sciences
- Experience in Publishing and Submissions is required.
Location
Chennai
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