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.

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 global 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 develop mitigation strategies to support successful approvals and lifecycle management.
- Effectively communicate complex regulatory issues to senior leadership and key stakeholders.

Required Qualifications

- Bachelor's degree in Life Sciences, Pharmacy, or a related scientific discipline (Advanced degree preferred).
- 8–10+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry.
- Demonstrated experience as a Global Regulatory Lead (GRL) or in a similar strategic global regulatory role.
- Strong experience partnering with or supporting US Regulatory Lead (USRL) activities.
- Extensive knowledge of US and global regulatory requirements and submission processes.

Proven experience leading:

- Global regulatory strategy
- Supplemental submissions (sNDA/sBLA)
- Health Authority interactions
- Post-Marketing Requirements (PMRs)
- Strong regulatory risk assessment and strategic decision-making capabilities.
- Experience working within cross-functional global development teams.

Preferred Qualifications

- Experience supporting approved products with multiple supplemental indications.

Therapeutic expertise in:

- Psoriatic Arthritis
- Experience with Deucravacitinib (DeUC) or similar immunology products is highly desirable.
- Experience leading general regulatory teams across multiple regions.

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📌 Global Regulatory Lead (España)
🏢 VBeyond
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