Dr. Reddys Laboratories Ltd. 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. Reddys offer a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, and differentiated formulations.
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The major therapeutic focus is on gastrointestinal, cardiovascular, diabetology, oncology, pain management, and anti-infective. Major markets include India, USA, Russia-CIS, and Europe apart from other select geographies within Emerging Markets. For more information, log on to www.drreddys.com
Position: Regulatory Affairs Analyst – API
Location: Hyderabad, Telangana, India
- Involve in the product selection by understanding the regulatory requirements of China FDA.
- To facilitate the smooth dossier preparation, by understanding the regulatory requirements and by communicating the requirements to the R&D 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 the china team for dossier preparation.
- Coordinate for PQC testing.
- Understand the PQC deficiency and coordinate with the R&D team to get the required information for the response.
- BE NOC application submissions with China FDA.
- Preparation of the GEA application and provide the appropriate information about the data to be generated at R&D / Mfg. pant in support of the application.
- Update the team on various reforms that happen 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 the R&D regulatory team.
- Evaluating the changes in life cycle management of the product for commercial products and providing the inputs for various application requirements.
- Coordinating with the commercial team and identifying the right time for variation filing to ensure that the supplies would not get disturbed.
- Coordination with the packaging development team to Organize the artwork review and approval process with the China team.
- Ability to manage conflicts well, driving the team towards a solution-oriented approach.
- Excellent interpersonal skills. Ability to interact with employees at all work levels and work on the front end.
- Having strong written and verbal communication skills, such that information is provided clearly and persuasively.
Experience: 3-7 Years of experience in Regulatory Affairs preferably with China or developed markets.
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