
Global Regulatory Affairs Specialist
6 days ago
Key Responsibilities:
- Develop and execute regulatory strategies to ensure timely submissions and approvals for assigned regions.
- Collaborate with regional teams to align on regulatory approaches and contribute to the development of departmental goals and objectives.
- Provide input into global regulatory strategy and participate in relevant regulatory boards to drive valuable insights.
- Establish relationships with Health Authorities (HAs) and facilitate the preparation and finalization of briefing books.
- Coordinate responses to HA requests, review and approve Clinical Trial Applications (CTAs), and Investigational New Drugs (INDs).
- Lead negotiations for regional approvals independently or with representatives from the DRA GPT.
- Ensure adherence to Novartis policy and guidelines, project feedback, and stakeholder engagement.
Requirements:
- Functional breadth and cross-cultural experience.
- Operations management, project management, and clinical trials expertise.
- Detailed-oriented skills, negotiation skills, and regulatory compliance knowledge.
- Strong analytical and problem-solving skills with the ability to work independently.
Preferred Skills:
- Clinical trials, drug development, lifesciences, and regulatory compliance.
Working Language: English.
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