api regulatory affairs manager in gurgaon

posted
contact
randstad india
position type
temporary
apply now

posted
location
gurgaon, haryana
function
Pharma, healthcare & lifesciences
position type
temporary
experience
6-12
reference number
57038
contact
randstad india

job description

api regulatory affairs manager in gurgaon

​​​​​​Managerail experience in Must into API * Compilation, preparation, and review of DMFs for US, Europe, Canada and ROW markets in specified eCTD or NeeS or CTD formats. * Responsible for API process development, DMF for US, European & Asian Countries. * Responsible for setting of specifications, knowledge of litigations matter related to Drugs & Cosmetics Act. * Setting specifications of API process development, knowledge of litigations matter related to Drugs and Cosmetics Act. * Responsible for checking complete CMC data including validations/verifications etc. performed to ensure accuracy of data. * Filing Annual updates and Amendments to various regions of submitted DMFs. * Handling queries obtained from different regulatory agencies and customers. * Compilation, preparation and review of Technical Package of APIs. * Compliance to audits of regulatory bodies especially USFDA and EU. * Generation of documents from R&D, Production, QC and QA of newly developed APIs. * Responsible for record keeping and to ensure correctness of records pertaining to department. * Responsible for all type of computer work and follow-ups. * Carrying out the initial assessment of Vendor Questionnaire and relevant documents. * To impart scheduled trainings of ICH guidelines pertaining to department

skills

API, Regulatory affairs, API process development, DMF, CTD

qualification

B-Pharma