We are seeking an experienced General 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 global regulatory teams across multiple regions.

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