Sr. Manager Regulatory Compliance
As part of the Regulatory Compliance, the Senior Manager supports Rigel’s Quality Systems and plays an essential role in managing quality and regulatory compliance related to Good Clinical Practice (GCP), pharmacovigilance and other activities. The incumbent will partner with internal key stakeholders to ensure studies activities, systems and processes are compliant with applicable regulatory requirements, procedures and study protocols.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Play a key role in the development of GCP and GLP Quality Systems and SOPs in compliance with applicable regulatory requirements and support department infrastructure development
• Partner with key stakeholders in the selection of clinical CROs or vendors for clinical study execution
• Maintain the list of approved vendors, annual audit schedule, clinical study audit plan, and CRO quality plan or agreement
• Manage and execute external audits of clinical investigator sites, vendors/service providers, CROs, clinical study documents (e.g. Clinical Study Reports, Trial Master Files, etc.)
• Ensure all audit related corrective and preventive actions are followed up according to Rigel’ SOPs
• Perform internal system/process audits to ensure compliance with company policies/procedures and regulatory requirements
• Represent Regulatory Compliance on clinical study team’s operational activities and provide guidance on GCP compliance matters
• Support clinical study teams during generation and closure of investigations, deviations and corrective/preventive actions
• Review GCP associated controlled documents (e.g. Clinical SOPs, protocol/amendments, study plans, case report forms, informed consents, etc.)
• Actively support inspection readiness activities and Regulatory Authority inspections
• Perform any other tasks as requested by the Director of Regulatory Compliance and/or Head of Regulatory, Quality Assurance and Compliance to support Quality oversight activities.
KNOWLEDGE AND SKILL REQUIREMENTS:
• BS/BA degree in biological Sciences, Chemistry or related field
• Minimum of 8 years in Clinical QA or Compliance role
• Experience in auditing clinical CROs, vendors and investigator sites
• Experience in supporting regulatory authority inspection and inspection readiness activities
• Ability to independently prioritize work and make decision with a high degree of initiative
• Detail-oriented with analytical with analytical skills to solve complex problems with a pragmatic approach
• Strong working knowledge and interpretation of FDA, EU and ICH regulations and guidelines
• Broad experience in the pharmaceutical industry with a strong clinical development understanding
• Strong verbal and written communication and interpersonal skills
• 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. 10 to 20% 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.