Position: HIM Director-Regulatory Affairs Manager

Location: Oakland CA USA 94612 (5 days onsite)

Duration: 12 Months (Possibility to extend/Convert)

Required Qualifications:

● Bachelor's degree with additional 10 years of progressively responsible experience managing quality compliance/assurance functions. Masters’ degree may substitute for two years of experience

● Comprehensive knowledge of FDA, ICH, EMEA regulations and guidelines

● Minimum five years in a quality management role with direct reports

● In-depth knowledge of 21 Code of Federal Regulation Parts 11, 312 and 820, and experience with Quality Management Systems

● Demonstrated experience identifying areas for improvement and implementing solutions;

●ensuring compliance with standards, regulations and company procedures; and administering successful programs within appropriate timelines

● Experience conducting training for quality assurance and/or regulatory affairs

● Ability to interact positively with all levels of staff and external contacts

● Proficiency in Microsoft Word, Outlook, Excel and PowerPoint

● Excellent verbal and written communication skills

● Experience adopting a flexible, proactive, and service-oriented approach

● Travel may be required

Desired Knowledge, Skills and Abilities:

● Certification in regulatory affairs, quality assurance or clinical research; ASQ (American Society for Quality) Certification is preferred

● Experience with on-site monitoring

● Expert planning and organization skills

● Strong attention to detail

● Exceptionally team focused; actively contributes to a positive and innovative work environment

● Able to demonstrate the highest ethical standards; promotes trust, respect and integrity

● Spanish language skills a plus

Additional Job details

• Oversee all aspects of Regulatory staffing, operations, systems, and expansion.

• Set vision and strategy for expanding regulatory teams that include both staff recruitment and retention strategies, and portfolio expansion strategies.

• Establish and operationalize policies, Standard Operating Procedures (SOPs), and quality assurance processes that ensure program compliance; partner with CRS Compliance and Regulatory Affairs Program to align with existing policies and systems.

• Partner with Clinical Research Management (CRM) to establish and maintain well-defined work flows, roles and responsibilities, and communications to ensure effective integration between regulatory and clinical operations.

• Oversee management and system support for an enterprise-wide eRegulatory and eSubject management system, Florence, including on-boarding, training, SOP management, user group engagement, trial migration, and quality control.

• Create roadmap and oversee implementation of new Florence modules, functionality, and integrations with other Consortium systems.

• Identify Regulatory improvement opportunities and lead improvement efforts within team, including technology solutions; identify opportunities for expanding solutions to Consortium study teams.

• Lead change management across study teams in support of increased regulatory management; establish faculty relationships and channels of communications to keep faculty apprised of central regulatory operations.

• Form strong partnerships with disease group teams and Clinical Trials Program leaders, developing standard report-outs for each centrally managed portfolio.