Regulatory Excellence Leader

2 days ago


Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time

Job Title: Regulatory Excellence Leader

This role involves leading the development and implementation of regulatory strategies for international markets, ensuring compliance with local regulations and facilitating the timely approval of our products.

Key Responsibilities:

  • Developing and executing regulatory plans to optimize product development and approval in international countries
  • Collaborating with cross-functional teams to ensure alignment on regulatory strategies and objectives
  • Providing expert guidance on international regulatory mechanisms and requirements
  • Managing the preparation and submission of clinical trial and marketing authorization applications
  • Contributing to the development of regulatory strategy documents and communicating key information to stakeholders
  • Directing the development of international label submission strategies and managing negotiation activities with cross-functional teams

Requirements:

The ideal candidate will have a strong background in international regulatory affairs, excellent communication skills, and the ability to work effectively in a global environment.

Education and Qualifications:

  • Doctorate degree or equivalent experience required
  • Strong knowledge of international regulatory principles and procedures
  • Excellent analytical and problem-solving skills
  • Ability to manage multiple priorities and work under pressure
  • Proven track record of successfully navigating complex regulatory environments

Skills and Qualifications:

  • Knowledge of international regulatory frameworks and guidelines
  • Excellent communication and interpersonal skills
  • Ability to work effectively in a team environment
  • Strong analytical and problem-solving skills
  • Proficiency in Microsoft Office Suite


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