Regulatory Affairs Director

POSITION SUMMARY:

Reporting to the Vice President of Regulatory Affairs & Quality Assurance, 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.

RESPONSIBILITIES:

• Provide strategic direction and oversight in the preparation of regulatory submissions
• Lead 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
• Act as regulatory operations representative for drug development programs via the project team by identifying, driving, tracking and delivering on key milestones/objectives
• 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
• Lend regulatory expertise and policy support for good pharmaceutical development practices (GCPs, GMPs and GLPs)
• Prepare regulatory operations Standard Operating Procedures (SOPs); provide regulatory review of SOPs from other departments as necessary
• Act as key liaison for ordering publications, guidelines, FOI requests, etc. for the department

• Setup training sessions for appropriate individuals and provides ongoing support as needed

REQUIREMENTS:

• Bachelor’s or advanced degree in scientific discipline; prefer a minimum of 12 years’ pharmaceutical experience, 8 years in regulatory affairs
• Direct experience in preparing registration (IND, NDA, BLA, and/or MAA) submissions required
• Strong knowledge of FDA/ICH and foreign regulations and guidelines for the development of small molecule products
• Experience with rare disease indications a plus
• Strong project management and organizational skills with emphasis on attention to detail
• Excellent interpersonal and verbal/written communication skills with the ability to build relationships at all levels of the organization
• Ability to work independently on multiple projects with tight timelines and minimal supervision
• 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.