Exp.: Min 4 to 5 years Designation: Executive- Regulatory Affairs Location: Mumbai Must have Key Skills: CTD/ ACTD/ CMC/ technical review/ Dossier/ MOH queries/ Variations/ Renewals Other essential skills: LATAM/ GCC/ MENA/ SEA/AFRICA/ change control/ Art work checking Job description: Common requirements: 1) Complete understanding of requirements & regulations of ASEAN/ AFRICA/LATAM/ GCC/ MENA markets wrt New submissions, Re-registration & Variations. 2) Prior experience of carrying out high quality CMC review of all kind of technical documentation & Art-works, 3) Review and /or Compilation of country specific/ CTD/ACTD dossiers for new submissions & renewal. 3) Variations submission 4) Must be an Individual contributor + Good team player. Specific requirements: 1) Collate, compile & author high quality CTD sections for M1, M2, M3, M4 & M5. 2) Detailed review of technical documents required for Regulatory submissions e.g. PVP/PVR/AMV/Stability report & Protocol/Specifications/ COAs/ BE study/ DMF etc. 3) Coordinate with Plant for required documents/ samples/ working standards etc. through emails/ phone calls for smooth running of Projects. 4) Utmost care is recommended to minimize the unwanted errors while working with documents i.e. authoring & reviewing the data. Preferred candidate profile Female and Male
Experience 3-6 yrs Package 4-5 lacs JD for Executive Commercial Project Management Tracking - R & D & Plant. Project Management Tracking to be done for all activities carried out at R & D from Product Initiation till Technology Transfer. Regular follow ups are taken for the implementation of revised documents. Ensuring products comply with legislation and quality assurance codes. Making sure that all QA records, data and information are available to Managers. Provide weekly and monthly reports too Senior Managers on performance. To assist HOD in administrative Activities as and when required. To collect and compile General Departmental MIS Reports for monthly performance review. To provide general support as and when required to department. Educe-SAP integration - Integration of BOM, RM and PM Inspection Plan, FG Inspection Plan, Task Closure. To communicate with RND, ADL and PDD department for related activities and resolve the same. To coordinate with all Cross Functional Departments as a Core Team Member regarding queries or issues. To Share Enquires about finished products, API or any other Pharma related material. To search for Manufacturers for Finished Products and API. To work on Brand-Names. To prepare application for any reimbursements offered by government agencies Like MAI (Pharmexcil). To follow up with different departments for pending activities related to any projects. To evaluate different agreements like CDA, NDA, Manufacturing /supply agreements. To keep regular check on pending work in due consultation with HOD.
FIND ON MAP