Urgent job openings for Regulatory Affiars Analyst @ Dr. Reddy’s Laboratories
Post Name: Regulatory Affiars Analyst
Qualification: M. Pharm with 3-5 years of experience in Regulatory Affairs preferably with China or developed markets.
- 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.
- Coordination with packaging development team to Organize the artworks review and approval process with China team.
Key Personal Attributes:
- A strong communicator having high energy levels with ability to influence & persuade others.
- 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.
- Internal DLT, plant RA, China RA, Portfolio, QA, QC, SCM, packaging development team.
- External – External API manufacturers, Excipients and packaging material suppliers