Duties & Responsibilities:   - Write & review regulatory submissions like IND, IMPD, MAA, NDA, DMF and documents for regulatory advices.  - Guidance to cross functional teams on regulatory expectations for US, EU, Japan and major markets.  - Ensuring regulatory compliance in cross functional teams and managing cross functional team deliverable.\  - Review of CMC, clinical, bio analytical development related documents & ensure compliance to CTD requirements  Functional/ Technical Skills:   - Sound knowledge of global regulatory guidelines like ICH, USFDA, EMA, Canada, Australia, Japan etc.  - Technical skills to understand & review the documents from cross functional teams on process development, analytical development, process scale up, product characterization, bio similarity, clinical & bio analytical development from regulatory perspective.  - At least 4 years of experience in regulatory function of pharmaceutical / bio pharmaceutical organisation  Behavioral / other skills:   - Good communication & interpersonal skills  - Should be familiar with system & software application.  - Good team player

Bangalore

Assistant/Deputy/Associate Manager - Regulatory Compliance - Biologicals 

Assistant/Deputy/Associate Manager - Regulatory Compliance - Biologicals  ,Job Description for Assistant/Deputy/Associate Manager - Regulatory Compliance - Biologicals  in Antal International in  Bangalore for (4-9) years of experience. Apply Now!

Job Description for Assistant/Deputy/Associate Manager - Regulatory Compliance - Biologicals  in Antal International in  Bangalore for (4-9) years of experience. Apply Now!