Senior Director Regulatory Operations

Arcus Biosciences, Inc.; Hayward (CA); On-site; USD 265,000 - 295,000; Full time

Benefits offered by this job

Stock programs

Performance-based bonus

Comprehensive benefits package

Job summary

Arcus Biosciences seeks a Senior Director of Regulatory Operations to independently manage multiple submission production and information management components in support of our product portfolio. This role aligns submission strategy with the global Regulatory strategy and reports to the VP of Regulatory Affairs.

The position oversees global regulatory submissions, publishing, archiving, and information management, coordinating with IT for platforms, and driving KPIs to optimize regulatory

Qualifications

• Bachelor or Master degree in Life Science with 10–12 years regulatory experience.
• 6+ years in regulatory operations leadership.
• Strong leadership and people management skills.
• Excellent written and verbal communication.
• Ability to manage multiple projects with moderate supervision.
• Knowledge of US and international regulations and guidelines.
• Experience with electronic submissions (eCTD) and publishing tools.
• Experience with Veeva Vault or similar DM systems.

Responsibilities

• Lead compliant GXP electronic systems and paper submission methods.
• Monitor regulations, develop action plans and tools.
• Support budgeting and vendor contract expenditures for submissions.
• Manage resourcing and contracting for external Regulatory Operations tasks.
• Coordinate submission planning, timelines and quality standards.
• Oversee worldwide electronic and paper submissions and readiness.
• Collaborate with stakeholders on major submissions and forecasts.
• Oversee disclosure and data sharing coordination with regulators.
• Ensure training and SOP development with other teams.
• Develop KPIs and analytics to drive Regulatory Strategy.

Skills

Leadership in management

Team player

Strong communication skills

Independent work

Detail oriented

Problem solving

Interpersonal skills

Project planning

Education

Bachelor’s degree in Life Science

Master’s degree in Life Science

Tools

ISI Toolbox

Veeva Vault for Submissions

Document Management Systems

Job description

The Senior Director of Regulatory Operations (RO) will be responsible for independently managing multiple operational components of regulatory submission production, maintenance processes, and/or Information Management in support of Arcus’s product portfolio. This position will also independently develop, implement, maintain and manage the submission strategy for areas of responsibility in alignment with the global Regulatory strategy.

This position is responsible for coordinating operational aspects of implementing Regulatory strategy and business that will contribute to helping Regulatory Affairs and ensuring global Regulatory Compliance. These groups include Regulatory Submission Publishing, Archiving, Regulatory Systems, Regulatory Project Management, Regulatory Information Management, and may include oversight on EU CTIS submission, Data Disclosure, and Regulatory Intelligence.

This position is responsible for ensuring that the core competencies of regulatory affairs are maximized and delivered on in the most efficient way possible. This includes managing electronic and paper publishing of submission documents, filing processes for global regulatory submissions and establishment of compliant electronic submission and archival processes for submissions; managing the interface with Information Technology for the selection, implementation and maintenance of technology platforms for Regulatory Affairs to enable the global submission process and all related Regulatory Affairs function; and ensuring that the Regulatory department is proactively managing guidance and regulation changes, developing and documenting processes, ensuring registration tracking and management is meeting corporate and health authority requirements.

Arcus is seeking candidates with a can-do attitude who operate with the highest integrity, embrace an atmosphere of continuous improvement, and share our commitment to data-driven decision making. This newly created position reports directly to the VP of Regulatory Affairs.

Responsibilities

Leadership role in the development of compliant GXP electronic systems and paper methods; plans, prepares, and tracks regulatory electronic documents and submissions ensuring conformance with regulatory requirements, guidelines, internal standards and timelines.

• Monitors and assesses business trends, pending relevant regulations or guidance documents and emerging technologies for potential regulatory operations impact, develop action plans and business tools accordingly.
• Supports budgeting and forecasting activities, including managing expenditures activities related to approved vendor contracts for outsourcing of regulatory submissions.
• Assist with resourcing and contracting for vendors that provide external Regulatory Operations tasks, oversee and coordinate vendors, and ensure project delivery
• Interact with and serve as resource for Regulatory Operations team to plan support of compliance activities and inspection readiness
• Work across company disciplines to ensure timely delivery of submission documents
• Manage worldwide regulatory electronic and paper submissions and regulatory operations team ensuring submission timelines and submission quality standards are met
• Collaborate with submission stakeholders to plan major submissions and the global roll-out of submissions. Based on these outputs prepare a submission forecast to ensure that the Regulatory team is adequately resourced.
• May oversee the general and overall coordination of Disclosure, Transparency and Data sharing of information to regulatory authorities and the public of information provided in Regulatory Submissions.
• Partner with departments outside of Regulatory, who are responsible for the content for a submission, to ensure quality Regulatory submissions are made on time.
• Organize and manage meetings with departments outside of Regulatory to coordinate, plan, and track submissions for Regulatory.
• Manage the Arcus formatting style guide and glossary to assist formatters in generating consistent, high quality formatted documents for submission (eg, StartingPoint).
• Leads the process of identifying submission preparation software, definition of user requirements, implementation of software systems, validation, and seamless establishment of these systems to support global Regulatory Affairs
• Responsible for the business administration of these platforms per software lifecycle management, including updates and upgrades.
• Ensures proactive management and engagement with regulatory agencies around new guidance and regulations, performing impact analysis on the company and ensuring that the Regulatory group is prepared to meet the requirements
• Assist with development of SOPs as necessary to ensure consistency and high standards in Regulatory Operations and coordination with other teams
• Working Knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to: amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc.
• Assist in the maintenance of document standards, templates, and procedures related to the formatting, publishing and archiving of both electronic and paper submissions according to company regulatory standards
• Work with project teams to maximize the use and value of document templates
• Develop KPIs and other analytics to drive Arcus Regulatory Strategy forward

Qualifications

• Bachelor’s degree in Life Science or other related discipline with 12 years regulatory experience or Master’s degree in Life Science or other related discipline and 10 years regulatory experience.
• Minimum of 6 years’ experience in a regulatory operations leadership role.
• Leadership skills in managing people
• A strong team player
• Strong written and verbal communication skills
• Ability to work independently with moderate supervision on multiple projects simultaneously
• Detail oriented with creative problem solving and troubleshooting skills
• Working knowledge of applicable U.S. and international regulations and guidelines
• Experience with electronic submissions (eCTD) and publishing tools, ISI Toolbox, and templates
• Experience with Veeva Vault for Submissions and/or other similar Document Management Systems
• Exceptional interpersonal skills with the ability to work individually and within multi-disciplinary teams
• Excellent oral and written communication skills and superior project planning skills.
• The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, innovative environment

This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $265,000 - $295,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.

EOE

Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets

Physical Requirements Office Setting

Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.