Global Regulatory Lead, Immunology & Inflammation

Planet Pharma; San Francisco (CA); On-site; USD 248,000 - 303,000; Full time

Job summary

Planet Pharma in San Francisco, CA, seeks a global regulatory lead (GRL) for immunology and inflammation to craft global regulatory strategy and oversee nonclinical and clinical submissions across development stages.

You will lead interactions with health authorities (FDA/EMA), supervise cross-functional teams, and guide planning, documentation, and submission execution to support approvals and lifecycle management. On-site role with competitive compensation.

Qualifications

• Bachelor's degree in life-sciences or related field required; advanced degree preferred.
• Minimum 12 years in Regulatory affairs strategy with immunology/inflammation focus.
• Knowledge of FDA, EMA and ICH guidelines and regulations.
• Experience supporting planning of clinical trials and marketing applications to health authorities.
• Track record in planning and executing major regulatory filings and ongoing maintenance.

Responsibilities

• Develop and implement global regulatory strategies for immunology/inflammation indications and identify risks.
• Collaborate with SVP Regulatory Affairs, development teams, and CROs to deliver development plans.
• Represent Regulatory Affairs on cross-functional development teams.
• Lead and manage high-quality global submissions (IND, CTAs, NDAs, MAAs) for early and late programs.
• Lead communication with global Health Authorities (FDA, EMA) and prepare for formal meetings.
• Develop and execute global regulatory strategies for long-term planning and potential expedited development.
• Guide cross-functional teams on regulatory risks and compliance with current regulations.
• Ensure adherence to regulatory activities and manage submission documents and HA communications.
• Contribute to requirements for future systems and tools for document management and submission planning.
• Track submission deliverables and dependencies; maintain submission plan templates.
• Participate in cross-functional process initiatives affecting submission processes and systems.
• Manage consultants and contractors as needed.

Skills

Regulatory strategy

Regulatory filing

Health authority interactions

Cross-functional collaboration

Project management

Communication

Independent work

Education

Bachelor's degree in life-sciences or related field

Tools

MS Project

Smartsheet

Excel

Job description

Planet Pharma in San Francisco, CA, seeks a global regulatory lead (GRL) for immunology and inflammation to craft global regulatory strategy and oversee nonclinical and clinical submissions across development stages.

You will lead interactions with health authorities (FDA/EMA), supervise cross-functional teams, and guide planning, documentation, and submission execution to support approvals and lifecycle management. On-site role with competitive compensation.