Lead Regulatory Specialist

3 days ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,80,00,000 - ₹ 2,30,00,000
Regulatory Lead - Clinical Development

We seek a seasoned expert in international regulatory affairs to oversee clinical development initiatives. This role involves advising global teams on regulatory requirements and implications for product development, including expedited First-in-Human studies, Orphan Drug designations, and regulatory reliance mechanisms.

  • Key Responsibilities:
  • Provide strategic regulatory direction and expertise to optimize product development, ensuring compliance with international regulations.
  • Develop and execute regulatory submissions for products within our portfolio, including clinical trials and marketing authorization applications.
  • Contribute to the development of international regulatory strategy documents and communicate effectively with cross-functional teams.
  • Develop and manage label submission strategies, lead negotiation activities, and ensure accurate label deviation requests and outcomes.
  • Support local regulatory teams in triaging queries from health authorities and provide guidance on international considerations.

Essential Qualifications and Skills:

  • Doctorate degree OR Master's degree with 10+ years of relevant regional regulatory experience OR Bachelor's degree with 12+ years of relevant regional regulatory experience
  • Comprehensive knowledge of international regulatory environments for clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labeling
  • Strong understanding of regulatory principles and their impact on projects and processes

Preferred Skills:

  • Ability to resolve conflicts and develop beneficial outcomes
  • Cultural awareness and sensitivity to achieve results across country, regional, and international borders

Required Soft Skills:

  • Strong communication skills, both oral and written
  • Ability to understand and communicate scientific/clinical information
  • Effective collaboration with global, local, and virtual teams
  • High degree of initiative and self-motivation
  • Planning and organizing abilities
  • Team-oriented focus on achieving team goals

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