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14 NDA Jobs in Bangalore / Bengaluru

Executive - Regulatory Affairs

2-5 years

Bangalore / Bengaluru

1 vacancy

Executive - Regulatory Affairs

Aurigene Oncology Limited

posted 15d ago

Job Description

Roles & Responsibilities

  • Will be responsible for preparation and submission of dossiers for NCEs and NBEs and will present it to relevant internal and external stakeholders.
  • will represent the company with Indian regulatory agencies, including CDSCO, RCGM, Central Bureau of Narcotics and Karnataka drugs control department.
  • will be responsible for regulatory submission process, including CT-NOC, marketing authorization applications, NOC & test license.
  • will follow up with regulatory agencies to obtain the approvals to support the regulatory timelines
  • will identify and assess regulatory risks associated with product filing.
  • will provide regulatory guidance to company personnel throughout the research and development process.

Competencies:

  • Understanding of various regulatory requirements for new drug development
  • Presentation & Communication Skills
  • Interpersonal Skills
  • Proficiency in Kannada

Desired Profile :

  • M. Pharm/M.Sc. with 2+ yrs of experience in submission of dossiers to Indian Regulatory agencies
  • Working experience of IND and NDA filing of NCE and NBE products

Employment Type: Full Time, Permanent

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