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.
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Our leadership and global colleagues are deeply experienced and forward-thinking. We have the capabilities, scale, and resources for growth and success. We are nimble and determined. We are Amneal and We make healthy possible.
We’re looking for entrepreneurial-minded team players who want to join hearts and minds in our quest to make healthy possible.
We’re looking for individuals who bring innovative ideas, a willingness to challenge the status quo, and a focus on delivering value and results. We also look for people who enjoy their work, want to grow with us, engage in our Responsibility commitments, and make a difference for our company, our patients, and our shareholders.
We offer opportunities across our development, manufacturing, marketing, and corporate support functions.
Position: Executive/Sr Executive Regulatory Affairs – OSD/Injectable for US Market
Location: Ahmedabad, Gujarat
- US ANDA complete life cycle handling experience, specifically the supplements and annual Reports submissions
- Basic Regulatory knowledge of Dosage forms incl. Solid oral (Tablet, Capsules), Liquid oral (Solution, Suspension)
- Basic Knowledge of, FDA guidance for Generic drugs, ICH Quality guidance especially Stability and Impurity requirements, Refuse to receive and Stability Question & Answer guidance, SUPAC guidance, supplement and Annual report related FDA guidance, Post approval CMC experience is highly desirable.
- Experience of handling change control assessment (via Track wise, QUMAS if explored), and accordingly prepare and submit relevant CBE0, CBE30, PAS, Annual Reports
- Review batch records, annual reports, and CMC documents
- Coordinate work with CMO, Regulatory CFT teams for regulatory submissions
- Clear verbal and written communication skills
- Good regulatory review skills of all CTD section related data
Experience: 3-7 Years
Salary: 3,00,000 to 8,00,000 INR CTC/PA