
Regulatory Strategy Lead
7 days ago
As a Global Regulatory Manager, you will be responsible for implementing regulatory strategy and managing operational activities across assigned regions. You will provide input into global regulatory strategy, contribute to the Regulatory Functional Plan (RFP) and Seed Document, and identify gaps or risks in global strategic plans.
Key Responsibilities:- Develop and implement regulatory strategies that align with business objectives
- Partner with regions to ensure regulatory compliance and alignment
- Manage Health Authority (HA) interactions, including determining requirements, setting objectives, and facilitating preparation of briefing books
- Drive coordination, planning, and submission of dossiers in assigned regions
- Review and revise regulatory documents to ensure accuracy and compliance
- Strong knowledge of regulatory submissions and approval processes in 1 or more major regions
- Experience leading regulatory submissions and approvals in at least 1 major region
- Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry
- Excellent interpersonal, communication, negotiation, and problem-solving skills
- Fluency in English as a business language
- A dynamic and collaborative work environment
- Opportunities for professional growth and development
- A competitive compensation package
If you are a motivated and experienced professional looking to take on a new challenge, please submit your application.
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