Regulatory Writing Director, Strategy & Submissions

Rigel Pharmaceuticals, Inc.; South San Francisco (CA); On-site; USD 180,000 - 212,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life and disability insurance

401(k) plan

Paid time off

Paid company holidays

Other benefits

Job summary

Rigel Pharmaceuticals, Inc. is seeking a senior Regulatory Writing lead reporting to the Vice President of Regulatory Affairs.

This role oversees the technical writing for regional/global submissions, aligning with therapeutic area directions and corporate objectives. Regular onsite presence is required at Rigel’s South San Francisco headquarters, with a structured onsite/hybrid schedule for residents in the area.

Qualifications

• Bachelor's degree in science with 15 years of pharmaceutical experience, including regulatory affairs.
• Advanced degree preferred.
• Hematology and/or Oncology experience preferred.
• Excellent oral and written communication skills for cross-functional discussions.
• Strong project/process leadership and ability to drive content and strategy.
• Ability to interpret, summarize and present statistical/medical information accurately.
• Capable of independent work and multi-project management.
• Familiar with regulatory guidance documents such as ICH.

Responsibilities

• Lead regulatory writing for regulatory submissions and cross-functional initiatives.
• Coordinate all regulatory documents and drive content and scientific strategy.
• Serve as primary regulatory writing contact for disease area cross-functional team.
• Develop SOPs and review regulatory procedures across departments.
• Mentor junior writers and train cross-functional staff on processes and best practices.
• Drive process improvements and share best practices with internal/external audiences.
• Support VP Regulatory Affairs and participate in submission/team meetings.
• Maintain knowledge of regulatory guidelines and industry standards.

Skills

Regulatory writing

Cross-functional collaboration

Project leadership

Scientific communication

Problem solving

Learning agility

ICH guidelines

Independent work

Time management

Education

Bachelor's degree in science

Advanced degree

Job description

Rigel Pharmaceuticals, Inc. is seeking a senior Regulatory Writing lead reporting to the Vice President of Regulatory Affairs.

This role oversees the technical writing for regional/global submissions, aligning with therapeutic area directions and corporate objectives. Regular onsite presence is required at Rigel’s South San Francisco headquarters, with a structured onsite/hybrid schedule for residents in the area.