Panacea Biotec | Senior Manager
22 hours ago
Job Summary:
Execution of successful dossier filing without any major query / deficiency.
Respond to the queries raised by the regulatory body within stipulated timelines and minimum queries.
Proper maintenance of records & their archival.
Key Responsibilities:
Compilation of the registration dossier in developed markets (ANDA, NDA & MAA)
Experience in regulatory aspects of Advanced Drug Delivery Systems such as nanoparticles/liposomal and microparticulate systems
Experience in regulatory aspects of drug-device combinations
Should be familiar with eCTD filing using docubridge software
To finalize structured product labeling (SPL) using LabelBridge software.
To review of different documents received from vendors, R&D, QA, QC, CRD & Regulatory authorities (e.g. DMF’s specifications, stability data, validation data, COA’s, MFC & CMC)
To respond queries / deficiencies from Different Regulatory Authorities.
Filing of IND and first to file Para IV type of application.
Maintenance of records & their archival.
Respond to the queries from different regulatory authorities in the stipulated timelines.
Skill Set Required :
Filing exposure for regulated markets for innovative and generic formulations.
Involvement in Tech Transfer, Development and regulatory requirements.
Understanding of requirements for CMC
e-CTD Submission.
Regulatory exposure from filings to launch
Due-Diligence of dossiers for in-licensing of the products
Guide stakeholders (R&D, Manufacturing, BD and Marketing) with respect to regulatory feedback.
Evaluation of regulatory consultants for the said market.
Budget preparation.
Challenges –
TAT Improvements in query response.
Minimize the queries / rejection for submissions.
Successful training of Software to all the employees.
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