Department : - Regulatory Affairs (China market). Formulations (OSD / Injectable)
Qualification :- M.Pharma/ MSc
Experiences :- 2 to 7 years
Region: China (Must)
Candidate should have strong experience in China market Guidelines.
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 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 internal 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 R&D / 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 Internal 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.
If you are looking for world class company kindly revert with your Updated CV along with below details to email@example.com
Reason for Change
Family willingness to move Hyderabad.
Salary: Not Disclosed by Recruiter
/ Clinical Research
Functional Area: Medical
Role Category: Drug Regulatory Affairs/Documentation
Role: Drug Regulatory Director
Employment Type: Full Time, Permanent