Global Regulatory Lead (España)

Global Regulatory Lead (España)

12 ago
|
VBeyond
|
España

12 ago

VBeyond

España

We are seeking an experienced Global Regulatory Lead (Global & US Regulatory) to lead global regulatory strategy for an approved immunology product within the Deucravacitinib (DeUC) Program. The successful candidate will partner closely with the US Regulatory Lead (USRL) and cross-functional global teams to develop and execute regulatory strategies supporting lifecycle management, supplemental indications, and post-marketing activities.

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This role requires strong expertise in global regulatory affairs, health authority interactions, regulatory risk assessment, and submission strategy, with preference for candidates experienced in psoriasis and psoriatic arthritis.
Key Responsibilities
- Lead the development and execution of global regulatory strategies for assigned products and indications.
- Partner with the US Regulatory Lead (USRL) to ensure alignment between global and US regulatory strategies.




- Drive regulatory planning and execution for supplemental submissions, lifecycle management activities, and post-marketing requirements (PMRs).
- Lead regulatory assessments and provide strategic advice to project teams regarding regulatory risks, opportunities, and submission pathways.
- Represent Global Regulatory on cross-functional project teams and Global Regulatory Teams (GRTs).
- Plan, prepare, and lead Health Authority interactions, including written responses and regulatory meetings.
- Evaluate evolving integral regulatory requirements and assess their impact on product development and commercialization.
- Collaborate with Clinical Development, Medical Affairs, Safety, CMC, Quality, Commercial, and regional regulatory teams to ensure successful execution of regulatory strategies.
- Support regulatory documentation, submission planning, and agency communications.
- Identify regulatory risks and d

📌 Global Regulatory Lead (España)
🏢 VBeyond
📍 España

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