Associate Director, Regulatory Writing

Job overview

Compensation is $180,000–$212,000 per year. The Associate Director, Regulatory Writing role is onsite in South San Francisco, CA, with regular onsite presence required for collaboration and business operations. in the listing’s structured salary data; the description states a national range of $180,000–$212,000 and a premium-market range of $200,000–$235,000 for the SF Bay Area, New York City, or Boston. The role reports to the Vice President of Regulatory Affairs at Rigel Pharmaceuticals. The associate director oversees technical writing for regional and global regulatory submissions and aligns submission strategies with therapeutic-area direction and corporate objectives. The role coordinates clinical and regulatory documents, timelines, and cross-functional input to support company milestones and compliant submissions.

What you'll do

• Support strategic regulatory submissions
• prepare regulatory documents in line with ICH and regional or global requirements
• serve as the regulatory-writing contact for cross-functional disease-area teams
• write or coordinate clinical and regulatory documents
• prepare and review SOPs
• establish document timelines and strategies
• train and mentor writers
• identify process improvements
• support regulatory and cross-functional meetings
• maintain knowledge of regulatory guidance.

What we're looking for

Skills & competencies

associate director

regulatory writing

south san francisco ca

onsite

rigel pharmaceuticals

regulatory submissions

regulatory affairs

ich guidelines

clinical documents

cross-functional leadership

pharmaceutical experience

some travel

Work arrangement

• Weekend coverage required

Benefits & perks

• Annual bonus program and equity incentive eligibility
• medical, dental, and vision coverage, life and disability insurance, flexible spending accounts, 401(k), paid time off, and paid company holidays.

Why this role

Requires a scientific bachelor’s degree and 15 years of pharmaceutical experience, including 10 years in regulatory affairs; direct experience preparing IND, CTA, NDA, BLA, and/or MAA submissions is required. Some travel may be required.

About the employer

Rigel Pharmaceuticals, Inc. is hiring for this role. Industry: All Other Professional, Scientific, and Technical Services. Sector: 54.