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 Formulation & Development for US Market
Location: Ahmedabad, Gujarat
Executive: 4+ Years Experience
Job Summary :
Responsible for working within the Specialty Matrix team to
- Preparation Regulatory docs for specialty products
- Hands-on Documentation like Development Reports, Master Batch Records with inputs from SMEs, and developed to a comprehensive level.
- Alignment of documents with the ICH, FDA, and other regulatory guidance expectation.
- Should have experience in developing global documentation and managing the same through their life cycle.
- Ensures all written documents conform to approved document format, standards, style, and terminology.
- Responsible for transcribing technical information from small scale research and development and scale-up batches into a good document report that is legible, well understood, and adequate for Abbreviated new drug application (ANDA) regulatory filing.
- Establish robust documentation practices in order to reduce review times and deviation by researching errors and inconsistencies in existing documents.
Jr Executive: 3+ Years Experience
Job Summary :
Responsible for working within the R and D Documentation Matrix team.
- Writes documents such as Master Batch Records, Development Reports, Quality Overall Summary, and Corporate SOPs in partnership with functional area subject matter experts and Business Co-owners ensuring these documents are written to a comprehensive level, and agreed upon by key stakeholders.
- Ensure all documents are aligned to ICH and FDA and other regulatory guidance expectations.
- The Technical Writer is expected to Track and provide document status updates to team leaders and managers as needed.
- Assessment of gaps in products or processes show initiative and good judgment in developing solutions, and then train writers or other stakeholders so that those solutions can be applied more broadly.
Desired Candidate Profile:
- Excellent written and oral communication skills, ability to work in a fast-paced team-oriented environment.
- Candidates must be open to working as per the US Time zone.
Salary: 3,00,000 to 8,00,000 INR CTC/PA