POSITION SUMMARY:

Reporting to the Vice President of Regulatory Affairs, this position is specifically responsible for the oversight of regional and/or global regulatory submissions and ensures strategies are in accordance with therapeutic area direction and corporate objectives. The Director, Regulatory Affairs will also oversee SOP development and other compliance functions in Regulatory Affairs as well as support inspection readiness for Rigel.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provides strategic direction and oversight in the preparation of regulatory submissions
• Leads cross functional project teams to deliver successful submissions/filings and outcomes with Health Authorities (HA) for highly complex programs by providing expert and effective project management oversight, direction, planning, and execution
• Acts as regulatory operations representative for drug development programs via the project team by identifying, driving, tracking and delivering key milestones/objectives
• Acts as back up to Vice President, Regulatory Affairs on an as needed basis
• Responsible for submission preparation tracker for more complex submissions, including follow-up with authors/reviewers to meet or exceed timeline expectations
• In conjunction with technical departments, acts as primary liaison with outside contractors to coordinate obtaining and completing regulatory documents/data
• Lends regulatory expertise and policy support for good pharmaceutical development practices (GCPs, GMPs and GLPs)
• Prepares needed regulatory operations Standard Operating Procedures (SOPs); provides regulatory review of SOPs from other departments as necessary
• Acts as key liaison for ordering publications, guidelines, FOI requests, etc. for the department
• Sets up training sessions for appropriate individuals and provides ongoing support as needed

KNOWLEDGE AND SKILL REQUIREMENTS:

• Bachelors degree in scientific discipline with 15 years’ pharmaceutical experience of which 10 years are in regulatory affairs
• Advanced degree preferred
• Direct experience in preparing registration (IND, NDA, BLA, and/or MAA) submissions required
• Strong written and verbal communication skills
• Self-starter able to work independently as well as being a team player
• Strong project management and organizational skills with emphasis on attention to detail
• Capable of effectively handling multiple projects
• Regulatory Affairs Professional Society or similar certificate a plus

WORKING CONDITIONS:

• PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.

• WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required.

Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.