Zydus Lifesciences – Regulatory Affairs (US Market)
Zydus Lifesciences, a renowned pharmaceutical company, is currently seeking experienced candidates for the position of Regulatory Affairs in the US market. If you have 6 to 12 years of experience in the US market and hold a qualification in B.Pharma, M.Pharma, or M.Sc, this is an excellent opportunity to join a leading organization at their corporate office in Ahmedabad.
As a Regulatory Affairs professional at Zydus Lifesciences, you will play a crucial role in the submission of ANDA (Abbreviated New Drug Application) and NDA (New Drug Application) documents. Your expertise in compiling and reviewing ANDAs (505j), 505(b)(2), and deficiency responses will be essential for ensuring regulatory compliance and successful submissions.
To be considered for this position, the following requirements must be met:
- Experience: 6 to 12 years of experience in the US market.
- Qualification: B.Pharma, M.Pharma, or M.Sc.
- Knowledge and Skills:
- Must have experience in ANDA/NDA submission.
- Proficiency in compiling (M1 to M5) and reviewing ANDAs (505j), 505(b)(2), and deficiency responses.
- Familiarity with the regulatory processes and guidelines of the US market.
Please note that only candidates with similar experience in the US market can apply for this position.
If you meet the requirements and are interested in applying for the Regulatory Affairs position in the US market at Zydus Lifesciences, please share your updated CV to the following email address: