CMC Regulatory Affairs, Senior Director

POSITION SUMMARY:

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

Salary Range

Premium (CA, NY) $242,250 to $285,000

National $218,035 to $256,500

*Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate's relevant qualifications, skills, and experience, as well as the location where this position may be filled.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provides strategic direction and oversight in the preparation of CMC and international regulatory submissions and CMC responses to Health Authority requests.
• Delivers successful CMC submissions/filings and outcomes with Health Authorities (HA) for highly complex programs by providing expert and effective project management oversight, direction, planning, and execution working in collaboration with Regulatory Affairs and CMC teams.
• Acts as regulatory operations representative for drug development CMC via the project team by identifying, driving, tracking and delivering on key milestones/objectives
• Responsible for CMC submission preparation 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 CMC regulatory documents/data
• Lends CMC regulatory expertise and policy support for good pharmaceutical development practices (GCPs, GMPs and GLPs)
• Provide regulatory guidance on CMC Change Assessments for development and commercial products.
• Lead Annual Reports for CMC, postmarketing supplements and CTA/IND Amendments for CMC changes
• Determine CMC requirements for INDs and NDA with regional regulatory requirements
• Provide CMC Regulatory leadership for Health Authority requests and/or inspections.
• Prepares regulatory operations Standard Operating Procedures (SOPs); provides regulatory review of SOPs from other departments as necessary

KNOWLEDGE AND SKILL REQUIREMENTS:

• Bachelors degree in scientific discipline with 15 years' pharmaceutical experience of which 10 years are in regulatory affairs
• Understanding of CTD
• 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.