Director, Global Regulatory Submissions (Hybrid)

Rigel Pharmaceuticals, Inc.; South San Francisco (CA); Hybrid; USD 200,000 - 260,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life and disability insurance

401(k) plan

Paid time off and holidays

Equity incentive awards

Job summary

Rigel Pharmaceuticals, Inc. in South San Francisco seeks a Director, Regulatory Affairs to oversee regional/global regulatory submissions, ensuring strategies align with therapeutic area direction and corporate objectives.

You will lead SOP development, regulatory operations, and inspection readiness while coordinating with outside contractors and internal teams. The role reports to the Vice President of Regulatory Affairs and requires strong project management, communication, and multi-project

Qualifications

• Bachelor's degree in a scientific discipline with 15 years' pharmaceutical experience, incl. 10 years in regulatory affairs.
• Strong written and verbal communication skills.
• Self-starter able to work independently as well as in a team.
• Strong project management and organizational skills with attention to detail.
• Ability to manage multiple projects concurrently.
• Regulatory Affairs certification (RAPS) or equivalent is a plus.

Responsibilities

• Oversee preparation of Ex-US regulatory submissions (EMA, PMDA, Health Canada, etc.).
• Lead cross-functional teams to deliver submissions and HA outcomes with expert project management.
• Act as regulatory operations representative for drug development programs and milestones.
• Maintain submission trackers and coordinate with authors/reviewers to meet timelines.
• Coordinate with outside contractors for regulatory documents/data.
• Provide regulatory policy support for GxP practices.
• Prepare regulatory operations SOPs and review SOPs from other departments.
• Liaise for publications orders, FOI requests, etc.
• Set up training sessions and provide ongoing support as needed.

Skills

Regulatory strategy

Project management

Cross-functional leadership

Regulatory submissions

Communication skills

Education

Bachelor's degree in a scientific discipline

Job description

Rigel Pharmaceuticals, Inc. in South San Francisco seeks a Director, Regulatory Affairs to oversee regional/global regulatory submissions, ensuring strategies align with therapeutic area direction and corporate objectives.

You will lead SOP development, regulatory operations, and inspection readiness while coordinating with outside contractors and internal teams. The role reports to the Vice President of Regulatory Affairs and requires strong project management, communication, and multi-project