Global Regulatory Affairs Specialist

5 days ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Title: International Regulatory Lead

About the Role:

We are seeking a highly skilled and experienced International Regulatory Lead to join our team. In this role, you will provide regulatory leadership and expertise for international countries for one or more products. Your key responsibilities will include collaborating with various functions and local regulatory teams to optimize product development and regulatory approvals in international countries.

Key Responsibilities:
- Provide regulatory direction and expertise on international regulatory mechanisms to optimize product development
- Plan and execute regulatory submissions (clinical trial, marketing authorization applications, and lifecycle management) for products within our portfolio
- Contribute to the development of international regulatory strategy documents and communicate them to others
- Direct and manage the international label submission strategy and lead negotiation activities with cross-functional teams
- Support local regulatory teams in triaging queries from health authorities and help identify existing responses to same or similar questions

Requirements:
- Doctorate degree or equivalent experience in the field of international regulatory affairs
- Comprehensive knowledge of regulatory principles and understanding of regulatory activities and their impact on projects and processes
- General awareness of registration procedures and challenges in international countries for clinical trial applications, marketing applications, and lifecycle management activities
- Strong communication skills, both oral and written

Benefits:
- Opportunity to work with a dynamic team and contribute to the development of innovative products
- Chance to develop your skills and expertise in international regulatory affairs
- Collaborative and fast-paced work environment

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