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Head Of Regulatory Affairs

Position: Manager/ Senior Manager (Head) - Regulatory Affairs 

Location: Bangalore


Desired Profile:

  • Degree in Life Science or related discipline required. Higher degree preferred (PharmD, M. Pharm, MSc, PhD, MBA).
  • 10+ Experience in developing and delivering global regulatory strategies for product development and approval
  • Working experience IND and NDA filing of NCE products at global regulatory stage would be preferred


Job Description, Key Skills and Competencies:

  • The candidate will represent the company with domestic and international regulatory authorities and business partners.
  • The candidate will be responsible for formulating global regulatory strategy for all the projects and will present it to relevant internal and external stakeholders.
  • The candidate will identify and assess regulatory risks associated with product filing. The candidate will define strategies to mitigate the risks.
  • The candidate will provide regulatory guidance to company personnel throughout the research and development process.
  • The candidate will set strategic direction and lead global regulatory submission process, including NOC & test license, marketing applications and core briefing packages.
  • The candidate will advise on global CTA / IND submission strategy.
  • The candidate will monitor and analyze appropriate regulatory agency activities in areas of interest to the company. Assess impact on programs.
  • The candidate will work closely with cross functional teams to prepare IND/NDA dossiers and regulatory response. 


Competencies:


  • Understanding of various regulatory requirements for new drug development
  • Presentation & Communication Skills
  • Team Management
  • Interpersonal Skills
  • Stakeholder Management
Posted
07/14/2022
Location
bangalore, KA, IN