Dr. Reddys Laboratories LtdRecruitment September 2020. Dr. Reddy€™s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products €“ Dr. Reddy€™s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.
Important Vacancy details:
- Post Name: Regulatory Affairs Analyst
- Education:M. Pharm
- Experienced:3 to 5 years
- Location: IPDO, Bachupally
- Salary :NA
- Openings :03
Job Description: We have requirement for the post of Regulatory Affairs Analyst in Dr. Reddys Laboratories Ltd !
· Involve in the product selection by understanding the regulatory requirements.
To facilitate the smooth dossier preparation, by understanding the regulatory requirements and by communicating the requirements to IPDO team. Listing the open points and ensuring the response be ready by the time we receive the deficiency.
· Evaluating the product suitability for tech transfer in China CMO’s and reviewing the various plant documents, coordinating with china team for dossier preparation.
· Coordinate for PQC testing.
· Understand the PQC deficiency and coordinate with IPDO team to get the required information for the response.
· BE NOC application submissions with China FDA.
· Preparation of GEA application and provide the appropriate information about the data to be generated at IPDO / Mfg. pant in support to the application.
· Update the team on various reforms happens at CFDA and evaluate the impact on existing products/products under evaluation/products planned in near future.
· Understanding the deficiency and preparation of deficiency response by coordinating IPDO regulatory team.
· Evaluating the changes in life cycle management of the product for commercial products and providing the inputs for variation application requirements.
· Coordinating with the commercial team and identifying the right time for variation filing to ensure that the supplies would not get disturbed.
Selection Process: The selection will be on the basis of Interview.
How to Apply : Click here for full details and Apply Online