Great Job opportunity as Regulatory Affairs Associate at Endo India- Apply before 30th June 2024

Endo India

Website Endo India

About Endo India

Endo India Par Formulations sounds like a company dedicated to making a positive impact in the pharmaceutical industry. Their focus on developing, manufacturing, and marketing safe and innovative pharmaceuticals shows a commitment to both patient well-being and advancing medical science. It’s promising to hear about their investment in cutting-edge equipment and facilities, as well as their dedication to ethical standards. With a growing portfolio of products, Endo seems like a dynamic company where employees can make meaningful contributions to improving patient quality of life. For individuals seeking a fulfilling career with long-term potential, Endo India Par Formulations appears to offer exciting opportunities.

Post: Regulatory Affairs Associate

Job Description:

  • Collation and Review of CMC Documents: Gather and assess CMC documents such as Master Formula Cards, PDR, BMR, BPR, Specifications, and Validation reports from various departments including F&D, ADL, QA, production, and packaging. Review the data for ANDA preparation, deficiency response, annual reports, and supplements.
  • Preparation and Review of ANDA Sections: Draft and scrutinize sections of ANDAs, ensuring accuracy and compliance with regulatory standards.
  • Compilation of Controlled Correspondences: Compile controlled correspondences related to excipients, Q1/Q2 queries, BE guidance, and general inquiries to the FDA.
  • Assistance in Regulatory Strategies: Aid in the development of regulatory strategies and their implementation to address complex issues that may impact the Company’s product portfolio and approval process.
  • Knowledge Sharing Sessions: Conduct knowledge sharing sessions as required to enhance team expertise and effectiveness.

Candidate Profile:

  • Qualification: M.Pharm
  • Experience: 1 year in CMC for Injectable formulations.

Additional Information:

  • Experience: 1 year
  • Qualification: M.Pharm
  • Location: Digha, West Bengal
  • Industry Type: Pharma / Healthcare / Clinical Research
  • Functional Area: Regulatory Affairs
  • End Date: 30th June 2024

This position offers an exciting opportunity for a qualified candidate to contribute to the regulatory affairs function in a dynamic pharmaceutical environment. If you possess the required qualifications and experience, we encourage you to apply before the deadline.

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