International Regulatory Expert

2 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878
International Regulatory Professional

We are seeking a highly skilled International Regulatory Professional to join our team. In this role, you will provide regulatory leadership and expertise for international countries, collaborating with various functions and local regulatory teams to optimize product development and regulatory approvals.

Key Responsibilities:

  • Develop and implement international regulatory strategies, providing regulatory support for in-country product registrations and life cycle management.
  • Advises global teams on regulatory implications and requirements relevant to the global clinical development, marketing applications plans and objectives.
  • Provides regulatory direction/expertise on international regulatory mechanisms to optimize product development.
  • Contributes to the development of international regulatory strategy documents and communicates to others as appropriate.

Requirements:

  • Doctorate degree or Master's degree with 3 years of relevant regional regulatory experience or Bachelor's degree with 5 years of relevant regional regulatory experience or Associate degree with 10 years of relevant regional regulatory experience or High school diploma/GED with 12 years of relevant regional regulatory experience.
  • Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes.
  • General awareness of registration procedures/challenges in international countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities.

Preferred Qualifications:

  • Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
  • Cultural awareness and sensitivity to achieve results across country, regional and international borders.

Our Ideal Candidate:

  • Has a strong understanding of international regulatory environments and practices.
  • Can communicate effectively with global, local and virtual teams.
  • Is proactive and self-motivated with a high degree of initiative.
  • Has excellent planning and organizing abilities.
  • Can manage multiple priorities successfully.

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