Senior Director Regulatory Operations (Office or Remote) - #258355

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, 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 Vice President 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 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 (e.g., Clinical Operations, Medical Affairs) 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.
• Manages 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.
• Ensures a consistent style of document presentation to maintain quality and ease of review, and adherence to company standards
• Develop the Arcus formatting style guide and glossary to assist formatters in generating consistent, high quality formatted documents.
• 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
• Working with Medical Writing, Clinical Operations and other teams on Data Disclosure requirements such as Clinical Trials.Gov.
• 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
  
  

Requirements

• 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.