Senior Manager

2 months ago

Bassi, India Panacea Biotec Full time

Senior Manager - Regulatory Affairs (EU & US Markets)

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:

  1. Compilation of the registration dossier in developed markets (ANDA, NDA & MAA)
  2. Experience in regulatory aspects of Advanced Drug Delivery Systems such as nanoparticles/liposomal and microparticulate systems
  3. Experience in regulatory aspects of drug-device combinations
  4. Should be familiar with eCTD filing using docubridge software
  5. To finalize structured product labeling (SPL) using LabelBridge software.
  6. 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)
  7. To respond queries / deficiencies from Different Regulatory Authorities.
  8. Filing of IND and first to file Para IV type of application.
  9. Maintenance of records & their archival.
  10. Respond to the queries from different regulatory authorities in the stipulated timelines.

Skill Set Required :

  1. Filing exposure for regulated markets for innovative and generic formulations.
  2. Involvement in Tech Transfer, Development and regulatory requirements.
  3. Understanding of requirements for CMC
  4. e-CTD Submission.
  5. Regulatory exposure from filings to launch
  6. Due-Diligence of dossiers for in-licensing of the products
  7. Guide stakeholders (R&D, Manufacturing, BD and Marketing) with respect to regulatory feedback.
  8. Evaluation of regulatory consultants for the said market.
  9. Budget preparation.

Challenges –

  1. TAT Improvements in query response.
  2. Minimize the queries / rejection for submissions.
  3. Successful training of Software to all the employees.

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