- Exposure with registration with India drug authority like CDSCO. - Should have you done management of application for grant of permission to manufacture new drug or investigational new drug for clinical trials, bioequivalence or bioavailability study for Indian market. - Experience with biologics and biosimilar will be added advantage. JOB PURPOSE : - To ensure the filing of required regulatory documents on time as per regulatory norms. - Take active participation from initiation of the projects and provide Regulatory strategy inputs to the team and the clients. - Liaise with Regulatory agencies, partners, customers, agents as appropriate. - Take lead for execution of regulatory submission documents for project and be the lead of any Regulatory discussion with the agencies or clients. - Review dossiers, regulatory documents, response to deficiencies as per the business needs.

Bangalore

Senior General Manager - Regulatory Affairs - Pharma  

Senior General Manager - Regulatory Affairs - Pharma   ,Job Description for Senior General Manager - Regulatory Affairs - Pharma   in Tutelage Professionals Pvt Ltd in  Bangalore for (15-20) years of experience. Apply Now!

Job Description for Senior General Manager - Regulatory Affairs - Pharma   in Tutelage Professionals Pvt Ltd in  Bangalore for (15-20) years of experience. Apply Now!