Shall be responsible for
Provide leadership in the development and commercialization activities for US & other regulated
Formulation Research, Process development, Technology Transfer and Overall Project Management of Pharmaceutical Dosage Forms leading to US ANDA, Europe CTD fillings for Regulatory Markets.
Monitoring stability studies.
Writing of PDRs /Compilation of MFR/MPR
Monitoring Pre- Exhibit /Exhibit batches
Coordination with various departments like IPM, Analytical, Regulatory, Pharmacokinetics, Quality Assurance and Production.
Implementation of SOPs /GMP Compliance .
Ph.D. / M. Pharma. With about 16 yrs experience in form development for regulated market.
Must have understanding regarding regulatory requirement of invitro invitro studies & PK Parameters