Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. Together, our team is working to build one of the most dynamic pharmaceutical companies in our rapidly changing industry.
Urgent Hiring For Core Regulatory Affiars @ Amneal Pharma, Ahmadabad
Candidate Must have :
- Exposure to US market .
- US Pre & Post approval submission experience supplement
- Plant RA candidates would not be a preference
- Candidates ready to relocate Ahmedabad should apply .
Vacancy details :
Pre-approval (OSD/Topicals): 01 Vacancy
- Designation : Executive/ Sr. Executive
- Experience : 3- 6 yrs
- Candidate must have exposure of Pre Approval for Topical and OSD for US Market. Candidate should have core exposure of RA.
Post-approval (Injectable): 01 Vacancy
- Designation : Executive/Sr. Executive
- Experience : 3- 6 yrs
- Candidate must have exposure of Post Approval for Injectable for US Market. Candidate should have core exposure of RA.
e-CTD Publishing (Regulatory Operations): 01 Vacancy
- Designation : Executive/Sr. Executive
- Experience : 3- 6 yrs
- Candidate must have exposure of e-CTD Publishing, Submission level publishing of PDF file like Uploading to eCTDXpress, External linking, Compilation, Validation and Submission to ESG Gateway for US Market.
Labelling (Regulatory Affairs): 01 Vacancy
- Designation : Executive/Sr. Executive
- Experience : 3- 6 yrs
- To ensure availability of all artwork, Preparation and review of labeling component of site transfer projects [i.e. word file, Redline, Clean file, Structured Product Labeling (SPL), Revise Structure Product Labeling
Interested candidates may share their updated CV at kavitriy@amnealindia.com